MOH CI REPORT 2009 2013 30JAN2016 REPORT TO PUBLISH 1 FEB 2016.pdf · National MOH CI Programme:...

Ministry(of(Health(Malaysia!!

NATIONAL(MOH(COCHLEAR(IMPLANT(PROGRAMME(5<YEAR(REPORT:(2009<2013!

(Advisor(

Datin!Dr!Siti!Sabzah!binti!Mohd!Hashim!!!

Editors((Dr!Zulkiflee!bin!Salahudin!

Dr!Philip!Rajan!!!

!!

Co<Editors:!!Mas!Diana!binti!Samsudin!Nur!Azyani!binti!Amri!

Farah!Dalila!binti!Mohamed!Tahir!Azmawanie!binti!Ab!Aziz!Noormala!binti!Anuar!Ali!

Norhana!binti!Abu!Seman@Talib!!

! January!2016!Medical!Development!Division,!Ministry!of!Health!Malaysia Jointly!published!by: National!ORL!Registry!–!Hearing!and!Otology!Related!Disease/Cochlear!Implant!and!Clinical!Research!Centre!(CRC) Contact: !Dr!Patimah!binti!Amin!Head!!Surgical!&!Emergency!Unit!(Cochlear!Implant!Programme)!Medical!Development!Division!!Ministry!of!Health!Malaysia!!Tel:!+603S88831159 Fax:!+603S88831155!Email:[email protected]!!Or!!National!ORL!Registry!–!Hearing!and!Otology!Related!Disease/Cochlear!Implant!Registry!Coordinating!Centre c/o!Clinical!Research!Centre!Hospital!Sultanah!Bahiyah!KM!6,!Jalan!Langgar 05460!Alor!Setar,!Kedah!Malaysia! Tel:!+604S740!6229 Fax:!+604S740!7373!Email:[email protected]!!Website:!https://app.acrm.org.my/ORL! Disclaimer Data! reported! was! acquired! from! the! National! ORL! Registry! –! Hearing! and! Otology! Related!Disease/Cochlear! Implant!&!data! source!providers! (MOH! facilities).! Interpretation!and! reporting! is!the!responsibility!of!the!editors!and!do!not!reflect!the!official!policy!of!the!publisher!or!the!authors’!affiliated!institutions.!Caution!is!advised!before!drawing!conclusions!from!the!data. This! report! is! copyrighted.! Reproduction! and! dissemination! of! this! report! in! part! or! in! whole! for!research,!educational!or!other!nonScommercial!purpose!are!allowed!with!prior!written!permission!from!the!copyright!holders!provided!the!source!is!fully!acknowledged. The!electronic!version!of!this!report!can!be!viewed!at!www.moh.gov.my1

TABLE(OF(CONTENTS(ACKNOWLEDGEMENT(.....................................................................................................................(i(FOREWORD(......................................................................................................................................(ii(MEDICAL(WRITING(COMMITTEE(............................................................................................(vii(PARTICIPATING(CLINICAL(SITES((SOURCE(DATA(PROVIDER)(.......................................(ix(ABBREVIATIONS(............................................................................................................................(xi(GLOSSARY(.......................................................................................................................................(xii(LIST(OF(TABLES(AND(FIGURES(................................................................................................(xiv(CHAPTER(1:(INTRODUCTION(.....................................................................................................(1(CHAPTER(2:(OBJECTIVE(...............................................................................................................(5(CHAPTER(3:(METHODOLOGY(.....................................................................................................(7(a.! Data!Collection!...........................................................................................................................................................!8!b.! Measuring!Level!Of!Outcomes!.............................................................................................................................!8!1.! Surgical+Complications+............................................................................................................................................+8!2.! Aided+Thresholds+........................................................................................................................................................+9!3.! Auditory+Perception+..................................................................................................................................................+9!4.! Speech+Production+.....................................................................................................................................................+9!5.! Timing+of+First+Word+Production+.....................................................................................................................+11!

c.! Factors!Affecting!Outcomes!................................................................................................................................!11!d.! Statistical!Analysis!..................................................................................................................................................!12!++++1.+++++Prelingual!...............................................................................................................................................................!12!2.! Postlingual+&+CrossDOver+Group+.......................................................................................................................+13!

e.! Limitation!Of!The!Study!.......................................................................................................................................!13!CHAPTER(4:(RESULTS(.................................................................................................................(14(Demographic!Data!...........................................................................................................................................................!15!a.! Prelingual!Group!.....................................................................................................................................................!15!1.! Surgical+Complications+.........................................................................................................................................+18!2.! Aided+Threshold+.......................................................................................................................................................+19!3.! Categorical+Auditory+Performances+(CAP)+Score+.....................................................................................+19!4.! Speech+Intelligibility+Rating+Scale+(SIR)+.......................................................................................................+22!5.! First+Word+Production+..........................................................................................................................................+24!6.! Factors+Affecting+Outcomes:+..............................................................................................................................+25!

b.! Post!Lingual!And!CrossPOver!Group!...............................................................................................................!28!1.! Surgical+complications+.........................................................................................................................................+28!2.! Aided+threshold+........................................................................................................................................................+29!3.! Categorical+Auditory+Performances+(CAP)+test+.........................................................................................+29!

CHAPTER(5:(DISCUSSION(...........................................................................................................(32(Age!Of!Diagnosis!And!Implantation!In!Prelingual!Patients!...........................................................................!33!Surgical!Outcomes!...........................................................................................................................................................!33!Functional!Outcomes!......................................................................................................................................................!34!CHAPTER(6:(SUMMARY(&(RECOMMENDATIONS(................................................................(36(Summary!..............................................................................................................................................................................!37!Recommendations!...........................................................................................................................................................!38!Plan!Of!Action!....................................................................................................................................................................!39!REFERENCES:(.................................................................................................................................(40(

National MOH CI Programme: 5-Year Report 2009-2013|ms i!

ACKNOWLEDGEMENT(!The!National!MOH!Cochlear!Implant!Programme!and!National!ORL!Registry!would!like!to!express!its!gratitude!and!appreciation!to!everyone!who!has!helped!make!this!report!possible.!!!!We!would!especially!like!to!thank!the!following:!!

Our!source!data!providers,!for!hard!work,!timely!data!collection!and!submission;!!!

• Hospital!Sultanah!Bahiyah,!Alor!Setar!• Hospital!Raja!Permaisuri!Bainun,!Ipoh!• Hospital!Raja!Perempuan!Zainab!II,!Kota!Bharu!• Hospital!Sultanah!Nur!Zahirah,!Kuala!Terengganu!• Hospital!Kuala!Lumpur!• Hospital!Sungai!Buloh,!Selangor!• Hospital!Tuanku!Jaafar,!Seremban!• Hospital!Sultan!Ismail,!Johor!Bharu!• Hospital!Queen!Elizabeth,!Kota!Kinabalu!

!DirectorPGeneral!of!Health!and!Director!of!Medical!Development!Division,!Ministry!of!Health!Malaysia!for!their!support!of!the!registry!and!approval!to!publish!this!report.!!Clinical! Research! Centre,! Hospital! Sultanah! Bahiyah,! Alor! Setar! for! its! continuing!support,!guidance!and!technical!support.!!!To!all!our!programme!advisors,!of!Universiti!Kebangsaan!Malaysia,!Universiti!Sains!Malaysia!and!Universiti!Malaya.!!!Members!of!the!medical!writing!committee!and!participating!clinical!sites!for!their!tireless!effort!and!commitment!to!the!program.!!

National MOH CI Programme: 5-Year Report 2009-2013|ms ii!

( ( ( ( Foreword'!By!the!Director,General!of!Health!Malaysia!

(

!

The!Ministry!of!Health!Cochlear!Implant!team!was!formed!in!2008!with!the!aim!to!start!

a!cochlear! implant!programme!within! the! framework!of! the!Ministry!of!Health.!While!

the! local! universities! provided! existing! services,! there! was! a! need! to! reach! out! to!

citizens!who!might!benefit!from!a!cochlear!implant,!particularly!deaf!children!for!whom!

this! technology! could! confer! hearing! and! profoundly! alter! their! course! of! life.! The!

infrastructure!of!the!Ministry!of!Health,!Malaysia!with!healthcare!facilities!in!every!part!

of!Malaysia,!provided!an!ideal!vehicle!for!a!nationwide!outreach.!!

The!implementation!of!the!programme!was!a!huge!undertaking!with!considerable!cost!

implications.!Staff!had!to!be!trained;!surgeons,!audiologists,!speech!therapists!as!well!as!

other!medical!staff.!Equipment!had!to!be!procured;!microscopes,!facial!nerve!monitors,!

surgical!drills,!mastoid!instruments;!to!name!a!few.!An!annual!allocation!of!about!RM5!

million!was!allocated!for!implants!alone.!!

Today,! the! programme! is! firmly! established! and!now!well! into! its! eighth! year.! In! the!

first!five!years,!184!Malaysian!citizens!benefitted!from!the!programme.!The!results!and!

outcomes!are!given!in!detail!in!this!document.!I!am!well!pleased!with!the!results,!with!

the! majority! of! the! recipients! benefitting! from! the! implant.! The! success! of! the!

programme!comes!as!no!surprise!to!me.!Meticulous!and!detailed!planning!by!the!ORL!

fraternity!and!Medical!Development!Division!took!place!well!before!the!first!implant!to!

ensure!a!smooth!and!seamless!implementation!of!the!programme.!

This!success!would!not!have!been!possible!without!the!support!from!our!advisors!from!

the! local!universities!who!have!obliged!to!share!their!experience!with!us.! I!am!deeply!

appreciative!of!their!guidance!and!their!generosity!with!their!time!and!knowledge.!

!

National MOH CI Programme: 5-Year Report 2009-2013|ms iii!

!

I!am!confident!the!second!five!years!of!the!programme!will!see!further!progress!with!a!

more! seasoned! and! experienced! team.! This! review,! the! first! of! its! kind! in! Malaysia,!

offers! a! comprehensive! review!of! a! national! cochlear! implant! programme,!which! is! a!

reflection! of! the! programme’s! maturity.! I! congratulate! the! ORL! fraternity! for! this!

success!and!look!forward!to!a!‘deafPfree’!Malaysian!society.!

(((((Datuk(Dr(Noor(Hisham(bin(Abdullah(Director<General(of(Health(Malaysia(

National MOH CI Programme: 5-Year Report 2009-2013|ms iv!

! ! ! ! !Foreword!!By!the!Director!of!Medical!Development!Division!

!

WHO! has! defined! Hearing! Impairment! as! one! of! the! major! public! health! and! social!

problems! and! over! 250! millions! people! are! estimated! to! suffer! from! hearing!

impairment.!With!the!current!advancement!of!medical!technology! ,!the!disability!from!

the!hearing!impairment!can!be!reduced.!

Cochlear! implant! has! been! accepted! worldwide! as! one! of! the! treatment! of! hearing!

impaired! patient! who! has! no! benefit! from! hearing! aid.! It! is! a! surgically! implanted!

electronic!device! that!provides! sense!of! sound! to! a!person!who! is!profoundly!deaf!or!

severely!hard!of!hearing.!Approximately!324,000!people!worldwide!have!received!the!

device!with!recipients!including!both!adults!and!children.!

Considerable! time,!effort!and!costs!were! involved! in!setting!up! the!Ministry!of!Health!

Cochlear! Implant! Programme! in! 2008.! The! good! relationship! between! the! ORL!

fraternity! and! Medical! Development! Division! has! enabled! smooth! and! rapid!

implementation!of!related!guidelines,!policies!and!services.!

An! audit! of! this! scale! is! no! easy! task! but! it! is! however! necessary.! This! review! of! the!

Ministry!of!Health!Cochlear!Implant!Programme!has!enabled!a!thorough!analysis!of!the!

strengths!of!the!programme!as!well!as!areas,!which!need!further!attention.!

I! am! greatly! pleased!with! the! success! of! the! programme.! Despite! the! high! costs,! the!

benefits! of! hearing! to! the! individual,! family! and! society! is! priceless.! The! Medical!

Development! Division! will! continue! to! support! and! develop! the! programme.! Every!

hearing!impaired!individual!in!our!community!must!never!be!marginalized!and!be!given!

the!opportunity!to!integrate!into!mainstream!society.!

!!!Dato’(Dr(Hj(Azman(bin(Hj(Abu(Bakar(Director(Medical(Development(Division,(Ministry(of(Health(

National MOH CI Programme: 5-Year Report 2009-2013|ms v!

! ! ! ! Foreword!!By!the!Programme’s!Advisor!

!

!

The!National! Cochlear! Implant! Committee!Ministry! of!Health! (MOH)! in! collaboration!

with!The!National!ORL!Registry!(Hearing!&!Otology!related!disease!/Cochlear!Implant)!

and!Clinical!Research!Centre!(CRC)! is!honored!to!present!the!first!Outcome!Report!of!

the! National!MOH! Cochlear! Implant! Programme.! The! Otolaryngologists,! Audiologists!

and! Speech! Therapist! with! tireless! support! from!Medical! Development! Division! and!

CRC! have! contributed! significantly! to! the! data! collection! and! data! analysis.! These!

results! are! particularly! crucial! to! assist! managements! planning,! improvement!

measures,! set! up! related!policies! and!help! estimate! financial! burden! for! hearing! loss!

cases!in!years!to!come.!

This! report! will! also! help! in! the! planning! of! preventive! and! early! rehabilitative!

measures!for!early!detection!of!hearing!loss!among!newborn!and!children.!

I!would!like!to!congratulate!Dr!Zulkiflee!Salahuddin!and!his!team;!the!editors,!members!

of!writing!committee!and!members!of!the!source!data!providers!for!their!contributions!

to!this!report.!It!is!indeed!a!bold!step!as!very!few!centers!worldwide!produce!Outcome!

Report!on!Cochlear! implantation!at!a!national! level.! !We!hope!that!every!members! in!

the! ORL! fraternity! will! continue! to! strive! to! improve! the! ongoing! data! collection! in!

order!to!produce!high!standards!of!evidence!based!reports!and!scientific!papers!in!the!

future.!

A! special! thanks! and! gratitude! to! the! Director! and! staff! of! CRC! Hospital! Sultanah!

Bahiyah!for!their!financial!and!technical!support.!!

!((((Datin(Dr(Siti(Sabzah(binti(Mohd(Hashim(Advisor,(National(MOH(Cochlear(Implant(Programme,(National(Advisor,(Otolaryngology(Services,(MOH.(

National MOH CI Programme: 5-Year Report 2009-2013|ms vi!

! ! ! ! !

!Foreword!!By!the!Chairman!Of!The!National!MOH!Cochlear!Implant!!

Report’s!Committee!

We!are! honored! and!privileged! to! present! this! 2008P2013!Ministry! of!Health! (MOH)!Cochlear! Implant!Programme!Outcome!Report.! The! idea!was!mooted!by!our!mentor,!Dato!Dr!Abd!Majid,!who!retired!in!early!2015,!two!years!before!he!ended!his!tenure!as!The! National! Advisor! in! Otolaryngology! (ORL)! and! chairman! of! the! MOH! national!cochlear!implant!committee.!!

Since! then,! members! of! the! writing! committee! and! source! data! providers! have! had!numerous! meetings.! It! was! a! lengthy! and! tedious! process! of! data! collection,! data!cleaning,! analysis,! literature! review! and! report! writing.! ! This! was! followed! by! the!tireless! effort! of! the! editorial! members! to! produce! a! comprehensive! yet! concise!document.! It! was! not! an! easy! task,! as! it! required! sheer! commitment! and! cohesive!teamwork!by!all!members!of!the!team.!The!task!of!completing!this!project!was!greatly!aided! by! the! constant! support! and! guidance! by! our! new! National! Advisor! in!Otolaryngology!(ORL),!Datin!Dr!Siti!Sabzah!who!is!also!involved!directly!in!this!report.!

We! would! like! to! extend! our! gratitude! to! the! Director! and! officers/staff! of! Medical!Development! Division! for! their! continuous! support! and! guidance! in! preparing! this!outcome!report.!

Clinical!Research!Centre!(CRC)!Hospital!Sultanah!Bahiyah!has!been!instrumental!in!the!data! collection! and! statistical! analysis.!We!would! like! to! convey! our! gratitude! to! the!Director!and!staff!for!their!financial!and!technical!support!in!preparing!this!report.!!

We!hope! this! report!will! provide! an! insight! into! the!MOH!National! Cochlear! Implant!service;! the! report! displays! its! achievement! and! recommendations! to! improve! the!service! in! the! future.!This!will! assist! future!planning!and! the!management!of!hearing!impaired!patients!in!our!beloved!country.!

!

+Dr(Zulkiflee(bin(Salahuddin(Chairman,(National(MOH(Cochlear(Implant(Report(Committee(

National MOH CI Programme: 5-Year Report 2009-2013|ms vii!

MEDICAL(WRITING(COMMITTEE(

NAME( REPRESENTATION(

Datin(Dr(Siti(Sabzah(Mohd(Hashim( Department!of!Otolaryngology,!Hospital!Sultanah!Bahiyah,!Alor!Setar,!

Kedah!

Dr(Zulkiflee(Salahuddin( Department!of!Otolaryngology,!Hospital!Raja!Perempuan!Zainab!II,!

Kota!Bharu!

Dr(Philip(Rajan( Department!of!Otolaryngology,!Hospiral!Raja!Permaisuri!Bainun,!

Ipoh!

Dr(Tengku(Mohamed(Izam(bin(Tengku(Kamalden(

Department!of!Otolaryngology,!Hospital!Sultan!Ismail,!Johor!Bharu!

Dr(Iskandar(bin(Hailani( Department!of!Otolaryngology,!Hospital!Kuala!Lumpur,!Kuala!

Lumpur!

Dr(Sobani(Din( Department!of!Otolaryngology,!Hospital!Sungai!Buloh,!Selangor!

Dr(Valuyeetham(Kamaru(Ambu( Department!of!Otolaryngology,!Hospital!Tuanku!Jaafar,!Seremban!

En(Shahrul(Aiman(bin(Soelar( Clinical!Research!Centre,!Hospital!Sultanah!Bahiyah,!Alor!Setar,!Kedah!

Pn(Mas(Diana(binti(Samsudin( Department!of!Otolaryngology,!Hospital!Kuala!Lumpur,!Kuala!

Lumpur!

Pn(Nur(Azyani(binti(Amri( Department!of!Otolaryngology,!Hospital!Sungai!Buloh,!Selangor!

Pn(Farah(Dalila(binti(Mohamed(Tahir( Department!of!Otolaryngology,!Hospital!Sultanah!Bahiyah,!Alor!Setar,!

Kedah!

Pn(Azmawanie(binti(Ab(Aziz( Department!of!Otolaryngology,!Hospital!Raja!Perempuan!Zainab!II,!

Kota!Bharu!

Pn(Noormala(Anuar(Ali( Department!of!Otolaryngology,!Hospital!Sungai!Buloh,!Selangor!

National MOH CI Programme: 5-Year Report 2009-2013|ms viii!

Pn(Norhana(binti(Abu(Seman@Talib( Department!of!Otolaryngology,!Hospital!Sultanah!Bahiyah,!Alor!Setar,!

Kedah!

En(Shahrom(bin(Ab(Rahman( Department!of!Otolaryngology,!Hospital!Raja!Perempuan!Zainab!II,!

Kota!Bharu!

En(Amirudin(bin(Mohamed( Department!of!Otolaryngology,!Hospital!Sultan!Ismail,!Johor!Bharu!

SUPPORTED(BY:(

Medical!Development!Division! !

• Dato’(Dr(Azman(bin(Abu(Bakar( !

• Dr(Patimah(binti(Amin(

Clinical!Research!Centre! !

• Ibtisam(binti(Ismail(

• Zainab(binti(Shafie(

!

National MOH CI Programme: 5-Year Report 2009-2013|ms ix!

PARTICIPATING"CLINICAL"SITES"(SOURCE"DATA"PROVIDERS)(

!1. HOSPITAL(SULTANAH(BAHIYAH(((

• Dr!Siti!Sabzah!binti!Mohd!Hashim!!• Dr!Norzi!binti!Gazali!!• Farah!Dalila!binti!Mohamad!Tahir!!!• Alia!Nadiha!binti!Alias!• Norasuzi!binti!Abdul!Halim!• Norhana!binti!Abu!Seman@Talib!• Nurbaiti!binti!Mohamad!Adli!

!!2. HOSPITAL(KUALA(LUMPUR(((

• Dr!Iskandar!bin!Hailani!(((• Mas!Diana!binti!Samsudin!(• Ummu!Athiyyah!binti!Abdul!Razak!• Ainnoor!Shafinas!binti!Buyong!• Marina!binti!Abdul!Malek!• Mohd!Safwan!bin!Yusof!

(3. HOSPITAL(RAJA(PEREMPUAN(ZAINAB(II(((

• Dr!Zulkiflee!bin!Salahuddin!!• Shahrom!bin!Ab!Rahman!((• Suhaiful!Syahril!bin!Suhaimi!• Farisatul!Ummi!binti!Aripin!• Azmawanie!binti!Ab!Aziz!(• Analiza!Anis!binti!Ab!Aziz!• Noorfadillah!binti!Ab!Halim!(

(4. HOSPITAL(SULTAN(ISMAIL,(JOHOR(BAHRU(((

• Dr!Tengku!Mohamed!Izam!Tengku!Kamalden!!• Amirudin!bin!Mohamed!!• Chong!Lun!Cheh(

(5. HOSPITAL(TUANKU(JAAFAR,(SEREMBAN,(NEGERI(SEMBILAN(((

• Dr!Valuyeetham!Kamaru!Ambu!!(• Norhidayah!binti!Mohd!Hatta!!• Hanita!binti!Hashim(• Wahida!binti!Mohd!Abdul!Wahab!(• Ernie!Heliza!binti!Yusof((!

National MOH CI Programme: 5-Year Report 2009-2013|ms x!

6. HOSPITAL(RAJA(PERMAISURI(BAINUN,(IPOH,(PERAK(((

• Dr!Philip!Rajan!!• Raja!Faizatul!Balqis!binti!Raja!Muzaffar!Syah(((• Mazly!Helmy!bin!Sulaiman!((• Noryantimarlina!binti!Abdullah!(• Lau!Wai!Yen(

((

7. HOSPITAL(SUNGAI(BULOH(((

• Dr!Sobani!bin!Din!((• Dr!Fadzilah!binti!Ismail!!• Nur!Azyani!binti!Amri!• Wan!Basirah!binti!Wan!Abdullah(• Noormala!binti!Anuar!Ali!!• Rozila!binti!Sumardi!!(!

8. HOSPITAL(SULTANAH(NUR(ZAHIRAH((

• Siti!Hazwani!binti!Yusoh!• Nurul!Fatehah!binti!Ismail!

!9. HOSPITAL(QUEEN(ELIZABETH(

(• Dr!Ong!Cheng!Ai!• Siti!Ladyia!binti!Mohd!Salleh!• Shahriman!bin!Shalihin!• Esther!Tuin!

!NON(SATELLITE(HOSPITALS:(

!! Hospital!Sultan!Abdul!Halim! :! Anida!Yusof!

! ! ! ! ! ! Ruby!Izyan!Atika!binti!Abu!Bakar!

Hospital!Tuanku!Fauziah! ! :! Shafida!Saiman!

! Hospital!Pulau!Pinang! ! :! Ng!Boon!Kheng!! ! ! ! ! ! ! Kok!Lee!Theng!

! Hospital!Bukit!Mertajam! ! :! Noorhafillah!binti!Abdul!Rahman!!

! Hospital!Sibu! ! ! ! :! Jenny!Lau!Yue!Jun!! ! ! ! ! ! ! Ling!Tiew!Hong!

! Hospital!Duchess!of!Kent! ! :! Merlinda!W.!Bernard!! ! ! ! ! ! ! Yeap!Choo!Er!

National MOH CI Programme: 5-Year Report 2009-2013|ms xi!

ABBREVIATIONS(!ORL! Otolaryngology!

!

NORL! National!Otolaryngology!Registry!

!

MOH! Ministry!of!Health!

!

UNHS! ! Universal!Neonatal!Hearing!Screening!

!

CAP! ! Categories!of!Auditory!Performance!

!

CI! ! Cochlear!Implant!

!

SIR! ! Speech!Intelligibility!Rating!

!

3FA! ! Three!Frequencies!Average!

!

HTL! ! Hearing!Threshold!Level!

!

dBHL! ! Decibel!Hearing!Level!

!

National MOH CI Programme: 5-Year Report 2009-2013|ms xii!

GLOSSARY(!PRELINGUAL(A!prelingual(deaf!individual!is!someone!who!was!born!with!a!hearing!loss!or!someone!whose!hearing!loss!occurred!before!they!began!to!speak.!!POSTLINGUAL(Post<lingual(deafness! is!deafness,!which!develops!after!the!acquisition!of!speech!and!language!!CROSS<OVER:((CrossPover! is! a! change! from!one! system!of! hearing! rehabilitation! to! another! i.e.! from!hearing!aid!to!cochlear!implant.!!SENSORINEURAL(HEARING(LOSS(Sensorineural(hearing(loss!(SNHL)!is!a!type!of!hearing!loss,!or!deafness,!in!which!the!root! cause! lies! in! the! inner! ear! (cochlea! and!associated! structures),! vestibulocochlear!nerve!(cranial!nerve!VIII),!or!central!auditory!processing!centers!of!the!brain.!!COCHLEAR(IMPLANT(A! cochlear( implant! (CI)! is! a! surgically! implanted! electronic! device! that! provides! a!sense! of! sound! to! a! person!who! is! profoundly! deaf! or! severely! hard! of! hearing.! The!receiver! picks! up! digital! signs! forwarded! by! the! transmitter,! and! converts! them! into!electrical! impulses.! These! electrical! impulses! flow! through! electrodes! contained! in! a!narrow,!flexible!tube!that!has!been!threaded!into!the!cochlea.!!(RE)HABILITATION(Providing!different!types!of!therapies!to!patients!who!have!deafness,!and!implementing!different!amplification!devices!to!aid!the!client’s!hearing!abilities.!Aural!rehab!includes!specific!procedures! in!which!each!therapy!and!amplification!device!has!as! its!goal! the!habilitation!or!rehabilitation!of!persons!to!overcome!the!handicap!(disability)!caused!by!a!hearing!impairment!or!deafness.!!NEONATAL(HEARING(SCREENING(An!objective!screening!method!performed!to! identify!neonates!who!may!have!hearing!loss!and!who!need!follow!up!or!more!in!depth!testing.!!HEARING(THRESHOLD(Minimum!sound! level!of! a!pure! tone! that!an! individual! can!hear!with!no!other! sound!present!!BEHAVIOURAL(ISSUE((Behavior! that! is! a! source! of! concern,! or! undesirable! that!may! impede! or! disrupt! the!course!of!rehabilitation!process.!

National MOH CI Programme: 5-Year Report 2009-2013|ms xiii!

HOME(BASE(PROGRAM(Continuation! of! therapy! session! at! patient’s! home! as! the! follow!up! of! formal! therapy!session! in! hospital.! This! is! to! be! conducted! by! parents! or! caregiver(s)! based! on! the!guide!given!by!the!therapist.!!SWITCH(ON(“Switch!on”!is!a!process!whereby!the!user’s!cochlear!implant!is!first!MAPped!(activated)!postPoperatively.!This!usually!occurs!in!two!to!three!weeks!postPoperation.!!!MAPPING(“MAPping”!is!a!process!of!getting!the!CI!user!a!specific!listening!program!(also!known!as!MAP)! The! MAP! usually! consist! of! minimum! levels! of! audibility,! maximum! levels! of!comfortability,!programming!strategy!and!other!associated!programming!options.!!!!

National MOH CI Programme: 5-Year Report 2009-2013|ms xiv!

LIST%OF%TABLES%AND%FIGURES(

Table!1:!The!Categories!of!Auditory!Performance!Score!(Archbold!et!al.,!1995)!.!.............!10!

Table!2:!Speech!Intelligibility!Rating!Criteria!(Cox!&!McDaniel,!1989)!...................................!11!

Table!3:!Descriptive!Statistics!for!Prelingual!Group!........................................................................!17!

Table!4:!Surgical!complications!................................................................................................................!18!

Table!5:Mean!aided!thresholds!for!pre!and!post!implant.!............................................................!19!

Table!6:!Descriptive!statistics!for!CAP!score!at!24!months!for!prelingual!group!...............!20!

Table!7:Changes!at!6!months,!12!months!and!24!months!of!CAP!score!.................................!21!

Table!8:!Descriptive!statistics!for!SIR!scale!at!24!months!.............................................................!22!

Table!9:Changes!at!6!months,!12!months!and!24!months!of!SIR!score!...................................!23!

Table!10:!Trends!in!the!duration!of!1st!word!production!by!“age!at!surgery!group”!.......!24!

Table!11:!Association!between!variables!and!CAP!score!at!24!months!..................................!26!

Table!12:!Association!between!variables!and!SIR!scale!at!24!months!....................................!27!

Table!13:!Surgical!Complications!(Postlingual!&!CrossPOver!Group)!......................................!28!

Table!14:Mean!Aided!Threshold!Pre!and!PostPimplant!for!Postlingual!&!CrossPOver!!!!!!!!!!!!!!!!!!!!Group!.................................................................................................................................................!29!

Table!15:!Descriptive!statistics!for!Postlingual!and!CrossPOver!Group!..................................!30!

Table!16:Changes!at!6!months,!12!months!and!24!months!of!CAP!score!for!Postlingual!&!!!!!!!!!!!!!!!!!!!!CrossPOver!Group!........................................................................................................................!31!

(

Figure!1:!Stages!of!candidacy!selection!...................................................................................................!3!

Figure!2:Changes!at!6!months,!12!months!and!24!months!of!CAP!score!................................!21!

Figure!3:Changes!at!6!months,!12!months!and!24!months!of!SIR!scale!..................................!23!

Figure!4:Trends!in!the!duration!of!1st!word!production!by!age!at!surgery!group!............!24!

Figure!5:Changes!at!6!months,!12!months!and!24!months!of!CAP!scorefor!Postlingual!&!!

!!!!!!!!!!!!!!!!!CrossPOver!Group!.........................................................................................................................!31!

1

CHAPTER 1

INTRODUCTION

National MOH CI Programme: 5-Year Report 2009-2013|ms 2!

INTRODUCTION(The!first!commercial!multichannel!cochlear!implants!(CI)!were!produced!in!the!

1980’s.! The! device!was! initially! used! for! deaf! adults! and! eventually!was! successfully!

used! on! children.! One! of! the! truly! amazing! aspects! of! this! new! technology! was! the!

outcome! in! congenitally!deaf! children;!who!were! able! to!hear! and! speak! and! even! fit!

into! mainstream! education.! The! downside! to! this! success! was! the! huge! costs! in! the!

device,!time!required!for!habilitation!and!the!unpredictability!of!the!outcome.!However!

cumulative! experience! over! the! years! have! enabled! professionals! to! formulate!

guidelines!on!candidate!selection!and!expected!outcomes.!

Cochlear! implantation! has! been! accepted! as! one! of! the! treatment! of! choice! in!

patients!with!severe!to!profound!hearing!loss!that!failed!or!having!minimal!benefit!from!

hearing! aids.! Based! on! FDA! (Food! and! Drug! Administration)! information,!

approximately! 324,200! people! worldwide! have! received! cochlear! implants! as! of!

December!2012!(NIDCD!Information!Clearinghouse,!2011).+

The! Ministry! of! Health! Malaysia! officially! started! its! own! cochlear! implant!

programme! in! the! year! 2008.! A! central! committee! was! formed! by! the! Medical!

Development!Division,!MOH!and!comprised!of!professionals!from!MOH,!representative!

from!Ministry!of!Education!and!advisors!from!the!local!universities.!At!the!inception!of!

the! programme,! seven! centres! were! selected! to! begin! this! service.! This! included!

Hospital!Sungai!Buloh,!Hospital!Sultanah!Bahiyah,!Alor!Setar,!Hospital!Raja!Permaisuri!

Bainun,! Ipoh,!Hospital! Tuanku! Ja’afar,! Seremban,!Hospital! Sultan! Ismail,! Johor!Bahru,!

Hospital! Raja! Perempuan! Zainab! II,! Kota! Bharu! and! Hospital! Queen! Elizabeth,! Kota!

Kinabalu.! Hospital! Kuala! Lumpur!was! later! added! as! one! of! the! satellite! hospitals! in!

2009.! In! addition! to! the! above! hospitals,! Hospital! Sultanah! Nur! Zahirah,! Kuala!

Terengganu!was!also!designated!as!a!cochlear!implant!rehabilitation!center!for!the!east!

coast.!(

Adequate!staffing!and!equipment!needs!were!first!addressed!to!start!the!service.!

Staffing! requirements! included! trained! ORL! surgeons! in! Cochlear! Implant! surgery,!

audiologists! and! speech! therapists.! Necessary! surgical,! audiological! and! habilitation!

equipment! were! acquired! for! these! centres.! These! include! high! end! operating!

microscopes,! surgical! instrument! sets,! mastoid! drills,! facial! nerve! monitors,!


electrophysiological! diagnostic! set,! hearing! aid! analyzer! and! programmer,! speech!

language!assessment!and!stimulation!tools.!!

A! Cochlear! Implant! Service! Operational! Policy! (SOP)! was! also! developed! to!

ensure!a!high!professional!and!ethical!standard!of!practice!is!achieved!in!the!Ministry!of!

Health!hospitals!(Cochlear!Implant!Service!Operational!Policy,!MOH,!2009).!!

Candidate! selection!was!done! through! a! rigorous!multidisciplinary! assessment!

by! ORL! surgeons,! audiologists,! speech! therapists,! pediatricians,! radiologists,! medical!

social! welfare! officers,! psychologists,! occupational! therapists! and! other! relevant!

professionals.! Primary! candidacy! evaluation! was! done! at! the! satellite! hospitals! with!

final!approval!at!a!centralized!meeting!held!at!regular!intervals.!Candidacy!selection!is!

based!on!the!criteria!set!in!the!service!operating!policy.!Majority!of!the!candidates!were!

provided! with! a! cochlear! implant! from! an! annual! grant! allocated! by! the! Ministry! of!

Health,!Malaysia.! The! remaining! candidates!were! either! funded! by! other! government!

agencies,!external!sources!or!selfPfunded.!!

!

Figure(1(:(Stages(of(candidacy(selection(

!

SURGERY(

NATIONAL!MOH!CI!COMMITTEE!

Final!approval!

SATELLITE!HOSPITALS!

Candidacy!selection!


Surgeries!were!performed!using!a!standard!technique!of!cortical!mastoidectomy!

via!a!post!auricular! incision!followed!by!posterior!tympanotomy.!The!electrodes!were!

introduced!either!through!a!cochleostomy!or!round!window!approach.!The!procedures!

were!performed!by!trained!cochlear!implant!surgeons!from!the!satellite!hospitals!in!the!

presence!of!a!senior!surgeon!from!the!central!committee.!The!implants!used!were!from!

MedPEl!and!Cochlear.!

Audiologist!will! perform! impedance! and! intraoperative!neural! telemetry!while!

the! patient! is! under! general! anesthesia.! The! test! result!may! provide! useful! objective!

information!on!electrode!placement!and!baseline!information!for!switch!on!and!future!

mapping!session.!Switch!on!of!the!device!is!scheduled!two!weeks!post!operatively!and!

followed!by!regular!MAPping!sessions.!

The!patients!will!then!undergo!intensive!audiological!and!speech!(re)habilitation!

programme.!The!cochlear! implant! team! in!each!satellite! center!monitors! the!patient’s!

progress.!The!surgical!and!functional!outcomes!are!discussed!in!the!Central!Committee!

regularly.!!

!

CHAPTER 2

OBJECTIVE

!!!!!!!!!!(((((((((((


OBJECTIVE(!

The!aim!of! this! report! is! to!evaluate! the! success!of! the!program!and! to! identify!areas!

that!require!further!attention!or!improvement.!

!a. To!describe!the!socio!demographic!variation!of!cochlear!implantees!in!the!

National!MOH!Cochlear!Implant!Programme.!!• To! determine! the! distributions! of! congenital,! syndromic! and! acquired!

hearing!loss!among!implantees.!!!

b. To!determine!the!surgical!outcomes!in!the!first!5!years!since!the!initiation!of!the!programme.!

!• To!determine!the!safety!of!the!surgical!procedure,!including!its!complication!

and!to!compare!results!with!other!Cochlear!Implant!Centres!worldwide.!!!

c. To!determine!the!functional!outcomes!in!the!first!5!years!since!the!initiation!of!the!programme.!!• To!determine!the!audiological!outcomes.!• To!determine!the!speech!outcomes.!

!!

d. To!determine!factors!affecting!outcomes!of!the!programme.!!!

!e. To!formulate!recommendation!to!improve!and!strengthen!the!programme!!

!• To!stimulate!and!facilitate!research!on!cochlear!implantation!based!on!

the!report.!!!• To!facilitate!future!financial!planning!and!projection!to!strengthen!the!

programme.!

CHAPTER 3

METHODOLOGY


a. Data!Collection!

All!cochlear!implants!recipients!under!the!MOH!Cochlear!Implant!Programme!from!

2009! to! 2013!were! included! in! this! review.! Data! was! obtained! from! the! National! ORL!

Registry! –! Hearing! and! Otology! Related! Disease/Cochlear! Implant! (NORL).! Additional!

information!was!acquired!from!the!CI!database!of!the!satellite!hospitals.!

b. Measuring!Level!Of!Outcomes!

The!outcomes!were!measured!by!surgical!complications,!aided!threshold,!auditory!

perception! and! speech! production.! ! Factors! contributing! to! the! outcomes! were! also!

analyzed.!!

1. Surgical(Complications(

A!surgical!complication!was!defined!as!an!unexpected!medical!event!related!to!the!

procedure! itself! and! causing! additional!morbidity! (e.g.! vertigo! or! infection)! or! a!

need!for!additional!surgery!(e.g.!electrode!migration).!

The! surgical! complications! were! characterized! as! major! or! minor.! Major!

complication!was!defined!as:!

I. a!significant!medical!problem!(e.g.!meningitis)!

II. an! event! leading! to! additional! major! surgery! due! to! a! patient! related!

problem! (e.g.! cholesteatoma! or! explantation! of! the! device! for! any! other!

reason!than!device!related!failure)!

III. any!degree!of!permanent!disability!(e.g.!permanent!facial!nerve!paresis)!

Any! complication! not! falling! into! at! least! one! of! the! abovePmentioned! categories!

was! classified! as! minor! complications.! Minor! complications! include! wound!

infection,! delayed! wound! healing! which! do! not! need! surgical! intervention! and!

transient!facial!paresis!(Jeppesen!&!Emil!Faber,!2013).!!


2. Aided(Thresholds(

The!aided!sound!field!thresholds!are!valuable!tools!in!assessing!the!performance!of!

hearing! aid! amplification,! cochlear! implant! and! middle! ear! implant.! It! is! widely!

used!in!pediatric!population!as!it!offers!behavioral!measures!(Hawkins,!2004)!

In! this! study! the! performance! of! three! frequencies! average! (500Hz,! 1000Hz! and!

2000Hz)!aided!thresholds!are!divided!into!two:!below!40dBHL!and!above!40dBHL.!

Studies!have!shown!that!with!aided! threshold!below!40dBHL,! the!child! is!able! to!

hear!at!least!50%!of!what!is!being!said!(Madell,!2015).!!

3. Auditory(Perception(

Auditory!perception!was!measured!using!Categorical!Auditory!Performances!(CAP)!

scale!(Table!1).!The!CAP!is!a!global!outcome!measure!and!it!comprises!a!nonlinear!

hierarchical! scale! of! auditory! receptive! abilities;! the! lowest! level! describes! no!

awareness! of! environmental! sounds,! and! the! highest! level! is! represented! by! the!

ability!to!use!the!telephone!with!a!known!speaker!(Archbold,!Lutman,!&!Marshall,!

1995;!Raeve,!2010).!

4. Speech(Production(

Speech!production!was!measured!using!Speech!Intelligibility!Rating!Scale!(SIR)!and!

timing!of!first!word!production.!

The!SIR!was!used!to!measure!the!outcome!of!cochlear!implantation!with!respect!to!

speech!intelligibility!recognizable!by!the!listener.!It!is!a!5Ppoint!rating!scale!ranging!

from! ‘prePrecognizable! words! in! spoken! language’! to! ‘connected! speech! is!

intelligible!to!all!listeners’!(Cox!&!McDaniel,!1989;!Raeve,!2010)!(Table!2).!


Category1 Categorical1Auditory1Performances1(CAP)1Criteria1

01

No1awareness1of1environmental1sounds:1Wearing!appropriate!aids!with!good!earmoulds,!the!child!does!not!alert!spontaneously!to!any!environmental!sounds.!Nor!has!the!child!been!reported!to!alert!to!environmental!sounds!

11

Awareness1of1environmental1sounds:1The!child!has!been!observed!to!make!a!spontaneous!reaction!to!about!half!a!dozen!different!environmental!sounds!(at!home,!at!school,!in!the!clinic!or!outdoors).!The!reaction!need!not!indicate!that!the!child!recognizes!the!sound,!only!that!he!or!she!has!detected!it.!

21

Response1to1speech1sounds:1The!child!will!obey!a!simple!command,!such!as!the!instruction!‘Go’!to!perform!an!action!such!as!rolling!a!ball!at!a!skittle,!when!delivered!in!a!normal!conversational!sound!level!at!a!distance!of!1F2!feet.!

31

Identification1of1environmental1sounds:1The!child!has!been!observed!to!identify!a!range!of!about!half!a!dozen!environmental!sounds!consistently!in!everyday!life!!(e.g.!doorbell,!telephone,!parent’s!voice,!traffic!etc).!Observers!are!confident!that!the!child!is!monitoring!his!or!her!environment!via!audition.!

41

Discrimination1of1some1speech1sounds1without1lipFreading:1The!child!can!discriminate!consistently!any!combination!of!two!of!!Ling’s!five!sounds!(/ss/,!!/sh/,!/ee/,!/oo/,!/aa/)!presented!with!live!voice!at!a!conversational!level!without!lipreading.!

51

Understanding1of1common1phrases1without1lipFreading:1The!child!is!able!to!identify!common!phrases!in!a!familiar!constraining!context.!For!example,!the!child!can!perform!the!IOWA!ClosedFSet!Sentence!Test!at!Level!A;!or!the!child!can!identify!simple,!familiar!questions!in!a!known!context!(e.g.!‘What’s!your!name?’,!‘Where’s!mummy?’,!‘How!old!are!you?’);!or!!the!child!can!identify!a!picture!correctly!from!a!limited!set!when!the!picture!is!described!verbally!

61

Understanding1of1conversation1without1lipFreading:1The!child!can!carry!out!a!simple!unscripted!conversation!with!a!familiar!talker!(e.g.!a!parent!or!teacher)!without!lipreading!in!a!quiet!setting.!The!child!must!be!able!to!respond!correctly!to!simple!questions!without!interaction!breaking!down!

71

Use1of1telephone1with1known1listener:11The!child!can!sustain!a!simple!unscripted!conversation!on!the!telephone!with!a!familiar!talker.!The!child!must!be!able!to!respond!correctly!to!simple!questions!without!interaction!breaking!down!

Table(1:(The(Categories(of(Auditory(Performance(Score((Archbold(et(al.,(1995)(.


Category( Speech(Intelligibility(Rating((SIR)(Criteria(

Category!1!Connected!speech!is!unintelligible.!Prerecognizable!words!in!spoken!language,!primary!mode!of!communication!may!be!manual.!

Category!2!Connected!speech!is!unintelligible.!Intelligible!speech!is!developing!in!single!words!when!context!and!lipSreading!cues!are!available.!

Category!3!Connected!speech!is!intelligible!to!a!listener!who!concentrates!and!lipSreads.!

Category!4!Connected! speech! is! intelligible! to! a! listener! who! has! little!experience!of!a!deaf!person’s!speech.!

Category!5!Connected!speech!is!intelligible!to!all! listeners.!Child!is!understood!easily!in!everyday!contexts.!

Table(2:(Speech(Intelligibility(Rating(Criteria((Cox(&(McDaniel,(1989)(

!

5. Timing(of(First(Word(Production(

The!timing!of!first!word!production,!was!used!to!measure!the!outcome!of!CI!with!respect!

of! the!emergence!of! first!meaningful!word!produced!post! implantation.!There! is! a! large!

increase!in!canonical!and!post!canonical!utterances!after!5!months!of!implant!use!(Ertmer,!

2001)! .! Increases! in! diversity! of! consonant! types! and! features! suggested! that! auditory!

information! was! used! to! increase! phonetic! diversity.! It! has! been! shown! that! this!

advancement! to! higher! levels! of! vocal! development! have! been! interpreted! as! signs! of!

progress!toward!meaningful!speech!and!phonological!organization.!

c. Factors!Affecting!Outcomes!

In!this!study,!a!number!of!parameters!were!looked!into!their!possible!correlation!with!the!

outcomes.! They! are! parents’! education! levels,! the! total! household! income,! frequency! of!

(re)! habilitation! sessions,! post! implant’s! parental! commitment,! post! implant! home!base!

program,!three!frequencies!average!aided!hearing!threshold!level,!compliance!of!cochlear!

implant!usage!and!behavioral!issue.!

Parental!commitments!were!evaluated!under!criteria!that!include!compliance!to!the!given!

appointment,!attend!appointment!on!time!and!parents!involvement!in!sessions.!

Post!implant!home!based!programme!(HBP)!were!assessed!by!consistency!in!carrying!out!

HBP!and!initiative!to!create!their!own!therapy!materials.!


For! behavioral! issues,! patients’! behavior! was! gauged! under! five! (5)! criteria! which!

includes,!the!evaluation!of!patient’s!compliance!towards!behavioral!task,!participation!in!

the! sessions,! attention! span,! parental! reports! regarding! the! patient’s! behavior! at! home!

and!sitting!behavior.!!!

d. Statistical!Analysis!

1. Prelingual!

The! analyses!were! performed!with! IBM! SPSS! Statistics! for!Windows! software! (Version!

20.0.! Armonk,!NY:! IBM!Corp).! Descriptive! statistics!were! utilized! for! selected! variables.!

The! results!were! presented! as! frequencies! and!percentage! for! categorical! data!while! in!

numerical,!which!is!normally!distributed,!was!presented!as!mean!and!standard!deviation!

while! median! and! interquartile! range! was! presented! for! numerical! data,! which! is! not!

normally!distributed.!!

Pearson! ChiPsquare! test! was! used! to! compare! differences! in! categorical! data! among!

groups! (Surgery! success,! 3FA! aided! HTL,! CAP! score! at! 24! months! and! SIR! scale! at! 24!

months)!while!Fisher's!Exact!was!used!as!an!alternative!if!the!assumptions!of!Pearson!ChiP

square!not!met.!!

Comparing!numerical! (Mean)!data,!which!are!normally!distributed!between!two!groups,!

was! analyzed! using! the! Independent! tPtest! while! onePway! ANOVA! test! was! used! to!

compare!more!than!three!groups.!!

For! numerical! (Median)! data! which! is! not! normally! distributed! cause! of! outliers,!

comparing!numerical!data!between!the!two!groups!was!analyzed!using!the!MannPWhitney!

test!while!KruskalPWallis!test!was!used!to!compare!more!than!three!groups.!Spearman's!

rank!correlation!coefficient!was!used!to!study!the!heteroscedasticity!correlation!between!

age!at!diagnosis,!waiting!time,!age!at!surgery,!age!at!switch!on,!duration!of!switch!on!and!

duration!of!1st!word!production.!!

Repeated! measures! ANOVA! was! used! to! test! changes! at! 6! months,! 12! months! and! 24!

months!of!CAP!score!and!SIR!scale.!The!symmetrical!distribution!of!probabilities!dividing!

the!alpha!level,!usually!0.05!into!two!parts!(Lang!&!Secic,!2006)!and!the!probability!value!

of!less!than!0.05!(pPvalue!<!0.05)!was!considered!as!statistically!significant.(


2. Postlingual!&!Cross,Over!Group!

The! analyses!were! performed!with! IBM! SPSS! Statistics! for!Windows! software! (Version!

20.0.! Armonk,!NY:! IBM!Corp).! Descriptive! statistics!were! utilized! for! selected! variables.!

The! results!were! presented! as! frequencies! and!percentage! for! categorical! data!while! in!

numerical!was!presented!as!mean!and!standard!deviation.!!

Pearson! ChiPsquare! test! was! used! to! compare! differences! in! categorical! data! among!

groups! (CrossPover! and! postlingual! cochlear! implant! patients)!while! Fisher's! Exact!was!

used! as! an! alternative! if! the! assumptions! of! Pearson! ChiPsquare! not! met.! Comparing!

numerical!(Mean)!data!between!crossPover!and!postlingual!cochlear!implant!patients!was!

analyzed!using!the!Independent!tPtest.!!

Repeated!measures! ANCOVA!was! used! to! test! changes! at! 6!months,! 12!months! and! 24!

months!of!CAP!score!by!controlling!for!age.!The!symmetrical!distribution!of!probabilities!

dividing! the! alpha! level,! usually! 0.05! into! two! parts! (Lang! &! Secic,! 2006)! and! the!

probability! value! of! less! than! 0.05! (pPvalue! <! 0.05)! was! considered! as! statistically!

significant.!

e. Limitation!Of!The!Study!

As! it! is! a! retrospective! study,! inherent! biases! in! data! recording! and! collection! were!

unavoidable.!!

CAP!&! SIR! could! not! be! analyzed! in! some! of! the! patients!who!were! implanted! at! later!

period!of!the!study,!as!they!did!not!complete!the!24!months!observation!period!at!the!time!

of!data!collection.!!

Data!collection!in!number!of!patients!was!incomplete!as!they!were!lost!to!follow!up.!

!

(

CHAPTER 4

RESULTS


Demographic!Data!

In!the!period!between!2009!and!2013!a!total!of!184!CI!surgeries!were!performed!of!

which!there!were!128!prelingual!deaf!children!15!cross!over!and!41!Postlingual!deaf!

patients.!

a. Prelingual!Group!

There!were!128!prelingual!cochlear!implant!patients!in!the!period!between!2009!and!

2013.!Nine!of!them!were!excluded!from!the!study!as!they!were!not!compliant!to!the!

follow!up!schedule.!

Out!of!119!implantees,!53!were!male!and!66!were!female.!In!term!of!ethnicity,!Malay!

was!majority!(66.4%)!followed!by!Chinese!(21.8%),!Indian!(9.2%)!and!others!(2.5%).!

The!age!of!implantees!range!from!11.8!months!to!70.3!months!old.!

Indication!for!cochlear! implantation!was!bilateral!severe!to!profound!sensorineural!

hearing! loss.! Majority! of! them! were! congenital! nonPsyndromic! patients! (111!

patients).! Others!were! syndromic! patients;! 3!Waardenburg’s,! 1! Charge!Association!

and!1!Usher!Syndrome.!They!were!2!patients!with!Cochlear!malformations!(Mondini)!

and!1!with!acquired!cause.!!

Mean! age! at! diagnosis,! waiting! time,! age! at! surgery,! and! age! at! switch! on! for! our!

patients! was! 25.3,! 17.9,! 43.1! and! 44! months,! respectively.! ! Only! 10.1%! of! these!

patients!had!neonatal!hearing!screening.!

Majority! of! the! parents! (63.9! to! 72.3%)! acquired! nonPtertiary! education.! Most! of!

them!(84.9%)!had!household!incomes!of!less!than!RM!5000!monthly.!


Variable1 n" (%)1 Mean1 (SD)1 (1 Min1 ,1 Max1 )1

Age1at1diagnosis,1months1 119!!

25.3! (9.65)! (! 1.6! ,! 47.4! )!

Waiting1time,1months1 119!!

17.9! (8.86)! (! 0.8! ,! 45.3! )!

Age1at1surgery,1months1 119!!

43.1! (9.69)! (! 11.8! ,! 70.3! )!

!<24! 7! (5.9)!

! ! ! ! ! ! !

!25S36! 14! (11.8)!

! ! ! ! ! ! !

!37S48! 62! (52.1)!

! ! ! ! ! ! !

!>49! 36! (30.3)!

! ! ! ! ! ! !Age1at1switch1on,1months1 119!

!44.0! (9.67)! (! 12.7! ,! 71.2! )!

Duration1of1switch1on,1months1 119!!

0.8! (0.28)! (! 0.3! ,! 1.6! )!

Duration1of11st1Word1Production,1monthsa1 96!!

7.0! (8.00)! (! 0.0! ,! 36.0! )!

1Gender1 1 ! ! ! ! ! ! ! !

!Male! 53! (44.5)!

! ! ! ! ! ! !

!Female! 66! (55.5)!

! ! ! ! ! ! !Race1 1 ! ! ! ! ! ! ! !

!Malay! 79! (66.4)!

! ! ! ! ! ! !

!Chinese! 26! (21.8)!

! ! ! ! ! ! !

!Indian! 11! (9.2)!

! ! ! ! ! ! !

!Others! 3! (2.5)!

! ! ! ! ! ! !Education1Level1(Father)1 1 ! ! ! ! ! ! ! !

!Tertiary! 43! (36.1)!

! ! ! ! ! ! !

!NonSTertiary! 76! (63.9)!

! ! ! ! ! ! !Education1Level1(Mother)1 1 ! ! ! ! ! ! ! !

!Tertiary! 33! (27.7)!

! ! ! ! ! ! !

!NonSTertiary! 86! (72.3)!

! ! ! ! ! ! !Household1Income1 1 ! ! ! ! ! ! ! !

!<!RM1000! 15! (12.6)!

! ! ! ! ! ! !

!RM1000!S!RM2499! 40! (33.6)!

! ! ! ! ! ! !

!RM2500!S!RM4999! 46! (38.7)!

! ! ! ! ! ! !

!RM5000!and!above! 18! (15.1)!

! ! ! ! ! ! !Etiology1of1Hearing1Loss1 1 ! ! ! ! ! ! ! !

!Congenital! 111! (93.3)!

! ! ! ! ! ! !

!Waardenburg!syndrome!

3! (2.5)!! ! ! ! ! ! !

!Cochlear!Malformation!

2! (1.7)!! ! ! ! ! ! !

!Acquired! 1! (0.8)!

! ! ! ! ! ! !

!CHARGE!Association!

1! (0.8)!! ! ! ! ! ! !

!Usher!syndrome! 1! (0.8)!

! ! ! ! ! ! !


1Neonatal1Hearing1Screening1 1 ! ! ! ! ! ! ! !

!Yes! 12! (10.1)!

! ! ! ! ! ! !

!No! 107! (89.9)!

! ! ! ! ! ! !Surgical1complications1 1 ! ! ! ! ! ! ! !

!Major! 2! (1.7)!

! ! ! ! ! ! !

!Minor! 4! (3.4)!

! ! ! ! ! ! !

!No! 113! (95.0)!

! ! ! ! ! ! !3FA1Unaided1HTL1(dBHL)1 1 ! ! ! ! ! ! ! !

!>80!dB! 119! (100.0)!

! ! ! ! ! ! !3FA1Aided1HTL1(dBHL)1 1 ! ! ! ! ! ! ! !

!<40!dB! 77! (64.7)!

! ! ! ! ! ! !

!>41!dB! 42! (35.3)!

! ! ! ! ! ! !Note :aPresented as median (interquartile range); SD = Standard Deviation.! ! ! ! ! ! ! ! ! !

Table(3:(Descriptive(Statistics(for(Prelingual(Group


1. Surgical(Complications(

In!our!series,!there!was!no!mortality.!!

There!were!2!major! complications;! the! first! patient! had!device! failure! 1! year! after!

implantation.! The! patient! was! reimplanted! in! the! same! ear.! The! second! patient!

developed! postauricular! abscess! one! year! following! implantation.! Management!

included!incision!and!drainage,!not!requiring!explantation.!

There!were!four!minor!complications.!One!patient!developed!transient!facial!paresis,!

which!recovered!with!conservative!measures.!Two!patients!had!wound!infection!and!

another! had!wound! breakdown!with! delayed!wound! healing.! They!were!managed!

conservatively.!There!was!no!complication!among!the!syndromic!children.!!

Summary!of!the!results!are!in!Table!4.!

MAJOR1COMPLICATION1 NO1OF1CASES1

Device!failure! 1!

Post!auricular!abscess! 1!

MINOR1COMPLICATION1 NO1OF1CASES1

Transient!facial!paresis! 1!

Wound!breakdown! 1!

Wound!infection! 2!

Table(4:(Surgical(complications


2. Aided(Threshold(

The!mean!aided!threshold!with!hearing!aids!measured!at!three!frequencies!average!

(500!Hz,!1000!and!2000!Hz)!prior!to!cochlear!implantation!was!80!dBHL.!Following!

implantation,!64.7%!patients!had!improvement!of!the!mean!aided!threshold!of!better!

than! 40! dBHL.! The! remaining! 35.3%! of! patients! showed!mean! aided! threshold! of!

between!40!to!80!dBHL.!

Table(5:Mean(aided(thresholds(for(pre(and(post(implant.(

3. Categorical(Auditory(Performances((CAP)(Score(

CAP(score!was!measured!prior!to!implantation!and!at!6,!12!and!24!months!interval!

post! implantation.! The! implantees!were! grouped! according! to! their! age! at! surgery!

(Group!1:!less!than!24!months,!Group!2:!25P36!months,!Group!3!37P48,!Group!4!!>49!

months).!Pre!implantation!mean!CAP!score!was!0!for!all!age!group.!!!

About!78%!of!our!implantees!able!to!discriminate!speech!sounds!without!lip!reading!

at! 24! months! (CAP! score! 4! and! above);! and! 51%! of! our! patients! are! able! to!

understand! common! phrases! without! lip! reading! (CAP! score! 5! and! above)!

irrespective!of!age!of!implant!(Table!6).!!

The! CAP! score! for! all! age! group! showed! significant! improvement! at! 6,! 12! and! 24!

months!followPup!after!implantation!(p<!0.001)!(Table!7!&!Figure!2).!!

The!CAP!score!continued!to!improve!with!time!in!all!age!group.!!Children!implanted!

before!24!months!of!age!showed!more!rapid!improvement!(steeper!curve)!compared!

to!the!other!groups.!!Group!1!and!2!showed!higher!score!in!mean!CAP!at!24!months!

follow! up! as! compared! to! Group! 3! and! 4.! However! they! were! not! significant!

statistically!!(p=0.236).!

1 Mean1Aided1Threshold1dBHL1(3FA)1 N1 Percent1%1

PRE1IMPLANT1 80! 119! 100!

POST1IMPLANT1<40! 77! 64.7!

>40! 42! 35.3!

Natio

nal M

OH C

I Pro

gram

me:

5-Y

ear R

epor

t 200

9-20

13|m

s 20

!

Varia

ble(

CAP(Score(at(24(mon

ths(

0(1(

2(3(

4(5(

6(7(

n"(%

)(n"

(%)(

n"(%

)(n"

(%)(

n"(%

)(n"

(%)(

n"(%

)(n"

(%)(

(!

!!

!!

!!

!!

!!

!!

!!

!!

Overall(

1!(1.0)!

2!(2.0)!

9!(9.0)!

10!

(10.0)!

27!

(27.0)!

32!

(32.0)!

1 5!(15.0)!

4!(4.0)!

Age(at(Surgery,(m

onths(

(!

!!

!!

!!

!!

!!

!!

!!

!<24!

0!(0.0)!

0!(0.0)!

0!(0.0)!

0!(0.0)!

2!(40.0)!

1!(20.0)!

2!(40.0)!

0!(0.0)!

!25.36!

0!(0.0)!

0!(0.0)!

2!(15.4)!

0!(0.0)!

4!(30.8)!

1!(7.7)!

3!(23.1)!

3!(23.1)!

!37.48!!

1!(2.0)!

1!(2.0)!

5!(9.8)!

5!(9.8)!

15!

(29.4)!

19!

(37.3)!

5!(9.8)!

0!(0.0)!

!>49!(31)!

0!(0.0)!

1!(3.2)!

2!(6.5)!

5!(16.1)!

6!(19.4)!

11!

(35.5)!

5!(16.1)!

1!(3.2)!

Table&6:&Descriptive&statistics&for&CAP&score&at&24&months&for&prelingual&group&

!

National MOH CI Programme: 5-Year Report 2009-2013|ms !

21!

Variable( n"CAP(Score(

p/valuea(6(months( 12(months( 24(months(Mean( (SD)( Mean( (SD)( Mean( (SD)(

( ! ! ! ! ! ! ! ! !Overall( 100! 2.6! (1.38)! 3.6! (1.39)! 4.4! (1.40)! <0.001!Age(at(Surgery,(months( (

! ! ! ! ! !0.236!

! <24! 5! 3.4! (1.95)! 4.2! (1.92)! 5.0! (1.00)! !

! 25/36! 13! 2.6! (1.56)! 3.9! (1.55)! 4.9! (1.75)! !

! 37/48! 51! 2.5! (1.32)! 3.3! (1.34)! 4.1! (1.33)! !

! >49! 31! 2.8! (1.31)! 3.7! (1.30)! 4.4! (1.38)! !!! ! !! !! !! !! !! !! !! !!

Table&7:&Changes&at&6&months,&12&months&and&24&months&of&CAP&score&

!

&

Figure&2:Changes&at&6&months,&12&months&and&24&months&of&CAP&score&

!

0

1

2

3

4

5

6

Pre op 6 months 12 months 24 months

CA

P Sc

ore

Overall <24 25-36 37-48 >49

National MOH CI Programme: 5-Year Report 2009-2013|ms 22#

4. Speech&Intelligibility&Rating&Scale&(SIR)&

Speech&Intelligibility&Rating&Scale&(SIR)&was$measured$prior$to$implantation$and$at$

6,$ 12$ and$ 24$ months$ interval$ post$ implantation.$ The$ implantees$ were$ grouped$

according$ to$ their$ age$ at$ surgery$ (Group$ 1:$ less$ than$ 24$ months,$ Group$ 2:$ 25@36$

months,$ Group$ 3:$ 37@48,$ Group$ 4:$ >49$ months).$ The$ mean$ SIR$ score$ at$ pre$

implantation$was$1$for$all$groups.$

At$ 24$ months$ post$ implant,$ about$ 71.1%$ of$ our$ implantees$ are$ able$ to$ produce$

intelligible$ speech$ in$ single$words$when$ context$ and$ lip$ reading$ cues$ are$ available$

(SIR$score$2$and$above);$and$38.1%$of$our$patients$are$able$ to$produce$ intelligible$

speech$ to$ a$ listener$ who$ concentrates$ and$ lip$ reads$ (SIR$ score$ 3$ and$ above)$

irrespective$of$age$of$implant$(Table$8).$$

The$SIR$score$for$all$groups$showed$significant$improvement$at$6,$12$and$24$months$

follow@up$after$implantation$(p<$0.001)$(Table$9).$$

The$SIR$score$continued$to$improve$with$time.$Children$implanted$before$24$months$

of$ age$ showed$ more$ rapid$ improvement$ (steeper$ curve)$ compared$ to$ the$ other$

groups.$$Group$1$and$2$showed$higher$mean$score$at$24$months$follow$up,$whereas$

Group$3$and$4$were$noted$to$have$poorer$performance$than$the$overall$score$(figure$

3).#

Variable(SIR(Scale(at(24(months(

1( 2( 3( 4( 5(n" (%)( n" (%)( n" (%)( n" (%)( n" (%)(

( # # # # # # # # # # #Overall( 28# (28.9)# 32# (33.0)# 30# (30.9)# 4# (4.1)# 3# (3.1)#Age(at(Surgery,(months(

( # # # # # # # # ## <24# 2# (40.0)# 1# (20.0)# 0# (0.0)# 1# (20.0)# 1# (20.0)#

# 25/36# 2# (16.7)# 2# (16.7)# 7# (58.3)# 0# (0.0)# 1# (8.3)#

# 37/48# 15# (30.0)# 19# (38.0)# 14# (28.0)# 1# (2.0)# 1# (2.0)#

# >49# 9# (30.0)# 10# (33.3)# 9# (30.0)# 2# (6.7)# 0# (0.0)#

# # # # # # # # # # # #

Table&8:&Descriptive&statistics&for&SIR&scale&at&24&months&


#

Variable( n"SIR(Scale(

p/valuea(6(months( 12(months( 24(months(

Mean( (SD)( Mean( (SD)( Mean( (SD)(

( # # # # # # # # #Overall( 97# 1.5# (0.74)# 1.8# (0.86)# 2.2# (1.01)# <0.001#Age(at(Surgery,(months(

( # # # # # # 0.187#

# <24# 5# 2.2# (1.79)# 2.4# (1.67)# 2.6# (1.82)# ## 25/36# 12# 1.6# (0.67)# 2.2# (0.94)# 2.7# (1.07)# ## 37/48# 50# 1.4# (0.64)# 1.6# (0.80)# 2.1# (0.92)# ## >49# 30# 1.5# (0.63)# 1.7# (0.70)# 2.1# (0.94)# #Note:aRepeated measures ANOVA (Time Effect) using Greenhouse-Geisser; SD = Standard Deviation.# # # #

Table&9:Changes&at&6&months,&12&months&and&24&months&of&SIR&score&

#

Figure&3:Changes&at&6&months,&12&months&and&24&months&of&SIR&scale&

0

1

2

3

Pre op 6 months 12 months 24 months

SIR

Sca

le

Overall <24 25-36 37-48 >49


0

5

10

15

<24 25-36 37-48 >49

Mon

ths

Age at surgery group

Duration of 1st Word Production

5. First&Word&Production&

The$ implantees$were$grouped$according$to$their$age$at$surgery$(Group$1:$ less$ than$

24$months,$Group$2:$25@36$months,$Group$3:$37@48$months$and$Group$4:$more$than$

49$months).$The$mean$duration$for$the$first$meaningful$word$production$for$all$age$

group$ was$ 7$ months$ after$ switch$ on.$ There$ is$ no$ significant$ statistical$ difference$

between$all$age$groups$(p=0.468).$$

Table&10:&Trends&in&the&duration&of&1st&word&production&by&“age&at&surgery&group”&

(

Figure&4:Trends&in&the&duration&of&1st&word&production&by&age&at&surgery&group&

Variable((

Age(at(surgery,(months(

p/value((

<24( 25/36( 37/48( >49(

"n" Mean( (SD)( n" Mean( (SD)( n" Mean( (SD)( n" Mean( (SD)(

( # # # # # # # # # # # # # #Duration#of#1st#Word#Production# #

6# 7.5# (7.25)# 12# 7.0# (10.50)# 47# 10.0# (9.00)# 31# 7.0# (9.00)# 0.468b#

bKruskal/Wallis#test,#presented#as#median(interquartile#range);# # SD#=#Standard#Deviation.#


6. Factors&Affecting&Outcomes:&

There$are$a$number$of$factors$associated$with$good$CAP$score$(score$more$than$5).$

They$are$children$with$no$behavioural$issue$(p<0.001),$mean$aided$threshold$better$

than$40$dBHL$(p=$0.037)$and$good$compliance$of$using$CI$of$8$hours$and$more$daily$

(p=$0.015).$

Other$ factors$ such$ as$ parents’$ education$ level,$ family$ household$ income,$ and$

frequency$of$rehabilitation$session,$post$CI$parental$commitment,$and$post$CI$home$

based$programme$do$not$show$significant$correlation$with$good$CAP$score.$$

SIR$ score$ is$ significantly$ associated$ with$ post$ CI$ parental$ commitment$ (p=0.023),$

Post$CI$Home$based$programme$(p=0.019),$no$behavioural$issue$(p=0.002)$and$good$

compliance$of$using$CI$of$8$hours$and$more$daily$(p=$0.001).$

Other$factors$such$as$parents’$education$level,$family$household$income,$frequency$of$

rehabilitation$sessions$and$mean$aided$threshold$better$than$40$dBHL$do$not$show$

significant$correlation$with$good$SIR$score.$$


Variables(

CAP(Score(at(24(months(

p/value"0/4( 5/7(

n" (%)( n" (%)(

# # # # # # #Household(Income(

( # # # 0.180b#

# <#RM999# 7# (70.0)# 3# (30.0)# ## RM1000#/#RM2499# 13# (36.1)# 23# (63.9)# ## RM2500#/#RM4999# 19# (51.4)# 18# (48.6)# ## RM5000#and#above# 10# (58.8)# 7# (41.2)# #Education(Level((Father)(

( # # # 0.721b#

# Tertiary# 18# (51.4)# 17# (48.6)# ## Non/Tertiary# 31# (47.7)# 34# (52.3)# #Education(Level((Mother)(

( # # # 0.901b#

# Tertiary# 14# (50.0)# 14# (50.0)# ## Non/Tertiary# 35# (48.6)# 37# (51.4)# #Frequency(of((Re)Habilitation(Sessions(

( # # # 0.619b#

# According#to#SOP# 15# (45.5)# 18# (54.5)# ## Not#according#to#SOP# 34# (50.7)# 33# (49.3)# #Post(CI(Parental(Commitment(

( # # # 0.057b#

# Poor# 18# (64.3)# 10# (35.7)# ## Good# 31# (43.1)# 41# (56.9)# #Post(CI(Home(Base(Program(

( # # # 0.112b#

# Poor# 25# (58.1)# 18# (41.9)# ## Good# 24# (42.1)# 33# (57.9)# #Behavioural(Issue(

( # # # <0.001b#

# Poor# 26# (86.7)# 4# (13.3)# ## Good# 23# (32.9)# 47# (67.1)# #3FA(Aided(HTL(

( # # # 0.037b#

# <40#dB# 29# (42.0)# 40# (58.0)# ## >41#dB# 20# (64.5)# 11# (35.5)# #Compliance(of(CI(Usage(

( # # # 0.015c#

# <7#hours#per#day# 8# (88.9)# 1# (11.1)# ## >8#hours#per#day# 41# (45.1)# 50# (54.9)# # Note:aIndependentt-test, presented as mean (standard deviation); bPearson Chi-square test; cFisher’s Exact test.

Table&11:&Association&between&variables&and&CAP&score&at&24&months&

&


Table&12:&Association&between&variables&and&SIR&scale&at&24&months&

Variables(

SIR(Scale(at(24(months(

p/value"1( 2/5(

n" (%)( n" (%)(

# # # # # # #Household(Income(

( # # # 0.052b#

# <#RM999# 3# (37.5)# 5# (62.5)# ## RM1000#/#RM2499# 6# (16.7)# 30# (83.3)# ## RM2500#/#RM4999# 10# (27.8)# 26# (72.2)# ## RM5000#and#above# 9# (52.9)# 8# (47.1)# #Education(Level((Father)(

( # # # 0.176b#

# Tertiary# 13# (37.1)# 22# (62.9)# ## Non/Tertiary# 15# (24.2)# 47# (75.8)# #Education(Level((Mother)(

( # # # 0.650b#

# Tertiary# 9# (32.1)# 19# (67.9)# ## Non/Tertiary# 19# (27.5)# 50# (72.5)# #Frequency(of((Re)Habilitation(Sessions(

( # # # 0.910b#

# According#to#SOP# 9# (28.1)# 23# (71.9)# ## Not#according#to#SOP# 19# (29.2)# 46# (70.8)# #Post(CI(Parental(Commitment(

( # # # 0.023b#

# Poor# 12# (46.2)# 14# (53.8)# ## Good# 16# (22.5)# 55# (77.5)# #Post(CI(Home(Base(Program(

( # # # 0.019b#

# Poor# 17# (41.5)# 24# (58.5)# ## Good# 11# (19.6)# 45# (80.4)# #Behavioural(Issue(

( # # # 0.002b#

# Poor# 15# (50.0)# 15# (50.0)# ## Good# 13# (19.4)# 54# (80.6)# #3FA(Aided(HTL(

( # # # 0.198b#

# <40#dB# 17# (25.0)# 51# (75.0)# ## >41#dB# 11# (37.9)# 18# (62.1)# #Compliance(of(CI(Usage(

( # # # 0.001b#

# <7#hours#per#day# 7# (77.8)# 2# (22.2)# ## >8#hours#per#day# 21# (23.9)# 67# (76.1)# #!Note:aIndependent#t/test,#presented#as#mean#(standard#deviation);#bPearson#Chi/square#test.#


b. Post'Lingual'And'Cross3Over'Group'

There$were$41$postlingual$cochlear$implant$and$15$cross@over$patients$in$the$period$

between$2009$and$2013.$

Among$56$implantees,$29$were$male$and$27$were$female.$In$term$of$ethnicity,$Malay$

was$majority$(78.6%)$followed$by$Chinese$(10.7%),$Indian$(8.9%)$and$others$(1.8%).$

The$age$of$implantees$range$from$3.6$years$to$63.2$years$old.$

Indication$for$cochlear$ implantation$was$bilateral$severe$to$profound$sensorineural$

hearing$ loss.$Majority$ of$ them$were$ idiopathic$ (36$patients).$Others$ are$ familial$ (2$

patients),$ meningitis$ (5$ patients),$ trauma$ (9$ patients)$ and$ ear$ related$ disease$ (4$

patients).$

1. Surgical&complications&

In$ our$ series,$ there$was$no$mortality.$ $ There$were$2$major$ complications,$ one$ is$ a$

case$of$electrode$migration$at$3$months$post$ first$ implantation,$and$6$months$post$

second$ implantation.$ Another$ case$ involves$ device$ failures$ at$ about$ one$ year$ post$

implantation.$Both$patients$were$reimplanted$in$the$same$ear.$There$was$no$minor$

complication.$$

MAJOR(COMPLICATION( NO(OF(CASES(

Device#failure# 1#

Electrode#Migration# 1#

Table&13:&Surgical&Complications&(Postlingual&&&CrossTOver&Group)


2. Aided&threshold&

The$ mean$ aided$ hearing$ threshold$ with$ hearing$ aids$ measured$ in$ the$ three$

frequencies$average$(500$Hz,$1000$and$2000$Hz)$prior$to$cochlea$implantation$was$

80$ dBHL.$ Following$ implantation,$ 82.1%$ patients$ had$ improvement$ of$ the$ mean$

aided$ threshold$ of$ better$ than$ 40$ dBHL.$ The$ remaining$ 17.9%$ of$ patients$ showed$

mean$aided$threshold$of$40$to$80$dBHL.$

(Mean(Aided(

Threshold((dBHL)(N( Percent(%(

PRE(IMPLANT( 80# 56# 100#

POST(IMPLANT(<40# 46# 82.1#

>40# 10# 17.9#

Table&14:Mean&Aided&Threshold&Pre&and&PostTimplant&for&Postlingual&&&CrossTover&Group

3. Categorical&Auditory&Performances&(CAP)&test&CAP$ score$ was$ measured$ prior$ to$ implantation$ at$ 6,$ 12$ and$ 24$ months$ post$

implantation.$The$implantees$were$grouped$according$to$cross$over$and$post$lingual$

group.$Pre$implantation$mean$CAP$score$was$0$for$all$age$group.$$$

At$ 24$ months$ post$ implant,$ 96.4%$ of$ our$ implantees$ were$ able$ to$ understand$

common$phrases$without$lip$reading$(CAP$score$5$and$above)$irrespective$of$age$of$

implant.$ Twenty@two$ implantees$ (39.3%)$ were$ able$ to$ use$ the$ telephone$ with$ a$

known$listener$(Table$14).$$

The$ CAP$ score$ for$ both$ groups$ (overall)$ showed$ significant$ improvement$ and$

achieved$CAP$score$of$6$at$24$months$after$implantation$(p<0.001)$(Table$15).$

The$CAP$score$showed$marked$improvement$at$the$first$6$months$post$implantation$

and$ continued$ to$ improve$ with$ time$ in$ both$ group.$ $ Post$ lingual$ group$ showed$

improvement$in$CAP$score$better$than$the$cross$over$group$within$6$and$12$months$

of$implantation$but$not$statistically$significant$(p=0.069)$after$age$adjustment.$$

#


#

Variable( n" (%)(

Group(( #

# Cross/over# 15# (26.8)#

# Postlingual# 41# (73.2)#Age,(yearsa( 22.5# (15.77)#Gender(

( ## Male# 29# (51.8)#

# Female# 27# (48.2)#Race(

( ## Malay# 44# (78.6)#

# Chinese# 6# (10.7)#

# Indian# 5# (8.9)#

# Others# 1# (1.8)#CAP(Score(at(6(months(

( #

# 1# 1# (1.8)#

# 2# 2# (3.6)#

# 3# 1# (1.8)#

# 4# 10# (17.9)#

# 5# 20# (35.7)#

# 6# 16# (28.6)#

# 7# 6# (10.7)#CAP(Score(at(12(months(

( ## 0# 1# (1.8)#

# 4# 4# (7.1)#

# 5# 15# (26.8)#

# 6# 21# (37.5)#

# 7# 15# (26.8)#CAP(Score(at(24(months(

( ## 0# 1# (1.8)#

# 4# 1# (1.8)#

# 5# 10# (17.9)#

# 6# 22# (39.3)#

# 7# 22# (39.3)#3FA(Aided(HTL(

( ## <40#dB# 46# (82.1)#

# >40#dB# 10# (17.9)#Etiology(

( ## Unknown# 36# (64.3)#

# Familial# 2# (3.6)#

# Meningitis# 5# (8.9)#

# Trauma# 9# (16.1)#

# Syndromic/Disease# 4# (7.1)## Note#:aPresented#as#mean#(standard#deviation).# # # #

Table&15:&Descriptive&statistics&for&Postlingual&and&CrossTOver&Group


0$

1$

2$

3$

4$

5$

6$

Pre@Op$ 6$months$ 12$months$ 24$months$

CAP&Score&

Overall$ Cross@Over$ Postlingual$

Variable( n"CAP(Score(

p$valuea(6(months( 12(months( 24(months(Mean( (SE)( Mean( (SE)( Mean( (SE)(

( # # # # # # # # #Overall( 56# 5.0# (0.20)# 5.7# (0.19)# 6.1# (0.18)# <0.001#Group(

( # # # # # # 0.069#

# Cross/over# 15# 4.8# (0.38)# 5.6# (0.37)# 6.2# (0.35)# ## Postlingual# 41# 5.2# (0.21)# 5.8# (0.20)# 6.0# (0.19)# ## # # # # # # # # #

Table&16:Changes at 6 months, 12 months and 24 months of CAP score for&Postlingual&&&CrossTover&Group&

#

#

Figure&5:Changes at 6 months, 12 months and 24 months of CAP score for&Postlingual&&&CrossTover&Group

&

&

&

(

CHAPTER 5

DISCUSSION


Age'Of'Diagnosis'And'Implantation'In'Prelingual'Patients'

From$our$study,$the$mean$age$at$diagnosis$is$25.3$months;$meanwhile$the$mean$age$

of$ surgery$ is$ 43.1$ months.$ Only$ 10%$ of$ these$ patients$ have$ undergone$ neonatal$

hearing$screening,$which$suggest$that$the$majority$of$the$patients$were$detected$via$

symptoms$of$delayed$speech$and$language$development.$In$MOH$hospitals$neonatal$

hearing$ screening$ is$ at$ infancy$ stage$ and$ only$ implemented$ in$ few$ state$ hospitals.$

Majority$ of$ the$ prelingual$ implantees$were$ not$ detected$ through$ neonatal$ hearing$

screening$ programme,$ therefore$ it$ is$ recommended$ we$ should$ consolidate$ our$

national$neonatal$hearing$screening$programme.$

Joint$Committee$of$Infant$Hearing$(JCIH)$recommends$for$universal$neonatal$hearing$

screening$ by$ 1$ month$ of$ age,$ hearing$ identification$ at$ 3$ months$ and$ hearing$

intervention$at$6$months$of$age.$Delay$in$diagnosis$and$intervention$(cochlea$implant$

surgery),$will$affect$the$speech$and$language$outcome$in$our$implantees.$$

Surgical'Outcomes'

Cochlear$ implantation$ Programme$ in$ the$ MOH$ has$ shown$ to$ be$ safe$ with$ low$

complication$rate.$

The$overall$ complication$rate$ in$our$ series$was$4.3%.$There$were$4$cases$of$major$

complication.$ There$ were$ two$ device$ failures,$ one$ electrode$ migration$ and$ one$

delayed$post$auricular$abscess.$$

The$ prelingual$ patient$ with$ device$ failure$ was$ detected$ at$ about$ 11$ months$ post$

implantation.$ This$ device$ was$ successfully$ explanted$ and$ reimplanted$ with$ a$ new$

device$ in$ the$same$ear.$The$device$ failure$was$due$to$dysfunctional$electrodes.$The$

second$ device$ failure$ occurred$ in$ a$ postlingual$ patient$ after$ about$ one$ year$ post$

implantation.$

The$particular$case$ involving$electrode$migration$cannot$be$explained$satisfactorily$

because$it$occurred$twice$in$the$same$patient,$using$the$same$electrode.$This$could$be$

due$ to$ electrode$ rejection.$The$patient$was$ successfully$ reimplanted$using$ another$

specially$designed$electrode$(FORM%electrode$by$Med@El).$One$case$of$post$auricular$


abscess$occurred$one$year$following$the$implantation$and$had$to$undergo$surgery$to$

drain$the$abscess,$however,$the$implant$remain$functional.$$

There$were$four$minor$complications.$One$patient$developed$transient$facial$paresis,$

which$recovered$with$conservative$measures.$Two$patients$had$wound$infection$and$

another$ had$wound$ breakdown$with$ delayed$wound$ healing.$ They$were$managed$

conservatively.$

The$ overall$ surgical$ complication$ in$ our$ program$ is$ low$ and$ it$ is$ comparable$with$

other$large$series$with$complication$rates$of$5$–$20%(Jeppesen$&$Emil$Faber,$2013).%

$We$ believe$ that$ our$ surgical$ technique$ of$ avoiding$ big$ surgical$ flap,$ practice$ of$

supervised$cochlear$ implant$ surgeries$by$senior$otology$surgeons$and$ the$usage$of$

facial$nerve$monitor$in$all$cases$have$contributed$in$minimizing$the$complications.$$$

Functional'Outcomes'

The$CAP$score$has$many$advantages,$and$the$inter@observer$reliability$of$the$CAP$has$

been$ widely$ accepted.$ Differences$ in$ language$ competency$ are$ not$ critical$ for$

performing$the$tasks$of$this$test$and$it$can$be$used$in$children$at$any$age(Suh$et$al.,$

2009).$ Other$ studies$ assessing$ auditory$ performance$ outcome$ in$ cochlea$

implantation$also$use$CAP$scores$for$adult$population(Kameswaran,$Raghunandhan,$

Natarajan,$&$Basheeth,$2006).$

SIR$ was$ used$ to$ measure$ the$ speech$ intelligibility$ of$ the$ implanted$ children$ by$

quantifying$their$everyday$spontaneous$speech.$It$is$a$time$effective$global$outcome$

measure$ of$ speech$ intelligibility$ in$ real$ life$ situations$ (Allen,$ Nikolopoulos,$ &$

O’Donoghue,$1998).$

After$implantation,$the$CAP$and$SIR$scores$of$implantees$(prelingual,$cross$over$and$

post$ lingual)$ increased$ with$ increasing$ time$ of$ implant$ use$ during$ the$ implant$

period.$These$findings$show$that$there$is$improvement$of$auditory$performance$and$

speech$intelligibility$in$the$majority$of$our$patients$post$implantation.$

$


In$ the$prelingual$ group,$patients$ implanted$early$ (less$ than$24$months)$performed$

better$in$their$CAP$and$SIR$scores$at$all$time$intervals$compared$to$those$implanted$

later$(more$than$24$months).$These$results$are$consistent$with$other$studies$that$find$

early$ implantation$ leads$ to$ better$ speech$ and$ language$ outcome$ (De$ Raeve$ &$

Wouters,$2013;$Zhou,$Chen,$Shi,$Wu,$&$Yin,$2013).$

$Early$implantation$allows$the$child$to$get$access$to$sound$and$spoken$language$from$

a$younger$age,$which$will$facilitate$better$speech$and$language$development.$$

Two$ important$ factors$ resulting$ in$ good$ CAP$ and$ SIR$ outcomes$ are$ implantees$

without$ behavioural$ issues$ (p<0.001,$ p=0.002)$ and$ good$ compliance$ of$ using$ CI$

(more$than$8$hours$daily)(p=0.015,p=0.001).$These$findings$suggest$that$behavioural$

assessment$ should$ be$ an$ important$ tool$ for$ candidacy$ selection.$ This$ study$ also$

shows$ that$ good$ compliance$ of$ CI$ usage$ is$ another$ important$ factor$ to$ have$ good$

outcome.$ In$ our$ programme,$ good$ compliance$ with$ HA$ usage$ is$ a$ prerequisite$ in$

candidacy$ selection,$ as$ we$ believe$ that$ this$ will$ reflect$ to$ the$ future$ CI$ usage$

compliance.$

Another$ variable$ that$ is$ associated$with$ high$ CAP$ score$ is$ mean$ aided$ thresholds$

better$ than$ 40dBHL.$ This$ is$ consistent$ with$Madell,$ 2012$ findings$where$ children$

with$hearing$ threshold$of$40dBHL$or$better$ is$able$ to$hear$at$ least$50%$of$what$ is$

being$said.$Therefore$this$correlates$with$better$CAP$scores.$

Our$ report$ also$ demonstrated$ that$ post$ CI$ parental$ commitment$ and$ good$

compliance$ to$ home$ based$ programme$ contribute$ to$ high$ SIR$ score$ (p=0.023,$

p=0.019).$ Therefore,$ it$ is$ important$ for$ family$ members$ to$ be$ involved$ and$ fully$

committed$in$providing$adequate$auditory$and$speech$input$at$their$home$settings$as$

per$ guided$ by$ the$ Speech$ Therapist$ and$ Audiologist.$ This$ aspect$ is$ especially$

important$ in$ our$Malaysian$ setting$due$ to$ the$ insufficient$ numbers$ of$Audiologists$

and$especially$Speech$Therapists$in$the$MOH$hospitals$and$limited$early$intervention$

program$for$the$hearing$impaired$nationwide.$$

Besides$all$of$the$above,$in$our$series,$we$find$that$the$first$meaningful$word$emerge$

by$seven$months$post$switch$on,$irrespective$of$the$age$of$implantees$at$surgery.$

.##

CHAPTER 6

SUMMARY &

RECOMMENDATIONS


Summary'

1. The$ MOH$ Cochlear$ Implant$ Programme$ has$ been$ a$ successful$ programme.$

The$ Medical$ Development$ Division,$ MOH$ has$ taken$ the$ right$ course$ and$

direction$to$implement$the$Cochlear$Implant$Programme$in$ministry$of$health$

hospitals.$

2. $The$surgical$procedures$have$been$shown$to$be$safe$with$successful$cochlear$

implantation$and$low$complications$rate$of$4.3%.$

3. The$ majority$ of$ implantees$ have$ significantly$ gained$ improvement$ in$auditory$and$speech$performance.$$$

In$prelingual$implantees,$64.7%$of$them$had$improvement$of$the$mean$aided$

threshold$ of$ better$ than$ 40$ dBHL.$ About$ 78%$ were$ able$ to$ discriminate$

speech$sounds$without$lip$reading$at$24$months$(CAP$score$4$and$above)$and$

71.1%$were$able$to$produce$intelligible$speech$in$single$words$when$context$

and$lip$reading$cues$are$available$(SIR$score$2$and$above).$

In$ the$postlingual$ implantees$group,$ following$ implantation,$82.1%$patients$

had$improvement$of$the$mean$aided$threshold$of$better$than$40$dBHL.$At$24$

months$ post$ implant,$ 96.4%$ of$ our$ implantees$ were$ able$ to$ understand$

common$phrases$without$lip$reading$(CAP$score$5$and$above).$

4. In$ the$ prelingual$ group,$ children$ implanted$ at$ younger$ age$ showed$ better$

auditory$ and$ speech$performance,$ and$hence$ the$need$of$ early$detection$of$

hearing$loss$in$neonates.$

5. Postlingual$ and$ cross@over$ implantees$ require$ a$ shorter$ duration$ of$

rehabilitation$period$to$achieve$targeted$auditory$performance.$

6. Children$ without$ behavioral$ issues$ who$ are$ compliant$ to$ cochlear$ implant$

usage$show$better$outcomes.$

7. Participation$ of$ family$ members$ in$ providing$ appropriate$ audiological$ and$

language$ rehabilitation$ is$ vital$ for$ successful$ outcome.$ It$ is$ important$ that$

they$ are$ fully$ involved$ and$ committed$ in$ providing$ adequate$ auditory$ and$

speech$input$to$the$implanted$child.


Recommendations'

Based$on$ this$outcome$review,$ the$ followings$are$our$ recommendations$ to$ improve$

and$maintain$successful$outcomes$leading$to$enrolment$of$the$prelingual$implantees$

into$mainstream$schooling:$

1. To$strengthen$and$to$expand$the$Universal$Neonatal$Hearing$Screening$program$

throughout$the$MOH$facilities$to$allow$early$detection$and$hearing$intervention$in$

the$prelingual$hearing$impaired$children.$

2. To$ address$ the$ contributing$ factors$ to$ poor$ outcome$ that$ affect$ speech$ and$

language$performance$among$the$implantees.$

3. Staffing:$Adequate$numbers$of$ personnel$ in$ the$ satellite$hospitals$which$ include$

Surgeons,$ Audiologists,$ Speech$ Therapists$ and$ trained$ paramedics$ to$ ensure$

optimum$service$delivered$to$patient.$$

4. To$ provide$ continuous$ training$ for$ members$ in$ the$ CI$ team$ to$ ensure$ that$ the$

program$is$up$to$date$and$conform$to$international$standards$of$practice.$$

5. To$create$awareness$of$hearing$loss$and$importance$of$early$intervention$among$

all$levels$of$health$care$workers$and$public$at$large.$

6. To$ create$ awareness$ and$ to$ stress$ the$ importance$ of$ parental$ commitment$ in$

home@based$program$to$maximize$rehabilitation$outcome.$

7. To$support$the$initiation$of$early$intervention$centre$for$hearing$impaired$children$

in$Malaysia$in$order$to$promote$oral$and$aural$method$of$communication.$

8. To$expedite$hearing$aid$acquisition$in$order$to$reduce$the$waiting$time$for$hearing$

aid$provision$and$cochlear$implantation,$especially$in$the$prelingual$age$group.$

9. To$ensure$a$consistent$cochlear$implant$grant$from$MOH$in$maintaining$continuity$

of$the$Cochlear$Implant$Program.$

10. To$ develop$ a$ suitable$ national$ assessment$ tool$ in$ audiological$ and$ speech$

outcomes$according$to$the$needs$of$the$local$population.$$

11. To$collaborate$with$other$agencies$in$relation$to$cochlear$implantation$research.$$


Plan'Of'Action'

1. Universal$ Neonatal$ Hearing$ Screening$ Program$ (UNHS)–$ to$ implement$ in$ all$

cochlear$implant$satellite$hospitals$within$two$years$and$five$years$for$others.$

2. Improve$ workflow$ process$ at$ satellite/local$ centers$ to$ expedite$ candidacy$

selection.$

3. To$conduct$road$shows,$regular$workshops$and$continuous$medical$education$

(CME)$to$ improve$awareness$and$knowledge$among$primary$care$physicians,$

pediatricians,$other$health$care$professionals,$NGOs$and$public$for$purpose$of$

early$referrals$of$suspected$hearing$loss$cases.$

4. Provision$ of$ training$ to$ all$ categories$ of$ personnel$ involved$ in$ Cochlear$

Implant$Programme$on$yearly$basis.$

5. To$establish$Parent$Support$Groups$in$all$satellite$hospitals$and$to$strengthen$

their$roles$in$order$to$improve$parents$understanding$and$commitment$in$the$

rehabilitation$process$in$two$years$time.$

6. To$ establish$ multidisciplinary$ early$ intervention$ centres$ in$ all$ satellite$

hospitals$for$children$with$hearing$and$speech/language$problems$within$the$

next$five$years.$

7. To$expedite$hearing$aids$acquisition$for$prelingual$(less$than$4$years$old)$and$

postlingual$ deaf$ children$ through$ networking$ with$ funding$ agencies$ e.g.$

Tabung$Bantuan$Perubatan$ (TBP)$ and$ Jabatan$Perkhidmatan$Awam$ (JPA)$or$

other$sources$to$fast@track$approval$for$application$of$hearing$aids.$

$


REFERENCES:&1. Allen,$M.$C.,$Nikolopoulos,$T.$P.,$&$O’Donoghue,$G.$M.$(1998).$Speech$Intelligibility$in$

Children$After$Cochlear$Implantation.$The%American%Journal%of%Otology,$19(6),$742–746.$

2. Archbold,$S.,$Lutman,$M.$E.,$&$Marshall,$D.$H.$(1995).$Categories$of$Auditory$Performance.$The%Annals%of%Otology,%Rhinology%&%Laryngology.%Supplement,$166,$312–314.$

3. Cox,$R.$M.,$&$McDaniel,$D.$M.$(1989).$Development$of$the$Speech$Intelligibility$Rating$(Sir)$Test$for$Hearing$Aid$Comparisons.$Journal%of%Speech,%Language,%and%Hearing%Research,$32(June$1989),$347–352.$doi:doi:10.1044/jshr.3202.347$

4. De$Raeve,$L.,$&$Wouters,$A.$(2013).$Accessibility$to$cochlear$implants$in$Belgium:$State$of$the$art$on$selection,$reimbursement,$habilitation,$and$outcomes$in$children$and$adults.$Cochlear%Implants%International,$14(s1),$S18–S25.$doi:10.1179/1467010013Z.00000000078$

5. Ertmer,$D.$J.$(2001).$Emergence$of$a$vowel$system$in$a$young$cochlear$implant$recipient.$Journal%of%Speech,%Language,%and%Hearing%Research :%JSLHR,$44(4),$803–13.$doi:10.1044/1092@4388(2001/063)$

6. Hawkins,$D.$B.$(2004).$Limitations$and$Uses$of$the$Aided$Audiogram.$Seminars%in%Hearing,$25(1),$51–62.$

7. Jeppesen,$J.,$&$Emil$Faber,$C.$(2013).$Surgical$Complications$Following$Cochlear$Implantation$In$Adults$Based$On$A$Proposed$Reporting$Consensus.$Acta%OtoMLaryngologica,$133(April),$1012–1021.$doi:10.3109/00016489.2013.797604$

8. Kameswaran,$M.,$Raghunandhan,$S.,$Natarajan,$K.,$&$Basheeth,$N.$(2006).$Clinical$Audit$Of$Outcomes$In$Cochlear$Implantation$An$Indian$Experience.$Indian%Journal%of%Otolaryngology%and%Head%and%Neck%Surgery,$58(1),$69–73.$

9. Madell,$J.$(2015).$The$Speech$String$Bean.$Retrieved$December$8,$2015,$from$http://hearinghealthmatters.org/hearingandkids/2015/the@speech@string@bean/$

10. NIDCD$Information$Clearinghouse.$(2011).$NIDCD$Fact$Sheet:$Cochlear$Implants.$Retrieved$December$7,$2015,$from$http://www.nidcd.nih.gov/staticresources/health/hearing/FactSheetCochlearImplant.pdf$

11. Raeve,$L.$De.$(2010).$A$Longitudinal$Study$on$Auditory$Perception$and$Speech$Intelligibility$in$Deaf$Children$Implanted$Younger$Than$18$Months$in$Comparison$to$Those$Implanted$at$Later$Ages.$Otology%&%Neurotology :%Official%Publication%of%the%American%Otological%Society,%American%Neurotology%Society%[and]%European%Academy%of%Otology%and%Neurotology,$31(8),$1261–1267.$

12. Suh,$M.,$Cho,$E.$K.,$Kim,$B.$J.,$Chang,$S.$O.,$Kim,$C.$S.,$&$Oh,$S.@H.$(2009).$Long$Term$Outcomes$of$Early$Cochlear$Implantation$in$Korea.$Clinical%and%Experimental%Otorhinolaryngology,$2(3),$120–125.$doi:10.3342/ceo.2009.2.3.120$

13. Ministry$of$Health$Malaysia.$(2009).$Cochlear%Implant%Service:%Operational%Policy.$Medical$Development$Division,$Ministry$of$Health$Malaysia.$

14. Zhou,$H.,$Chen,$Z.,$Shi,$H.,$Wu,$Y.,$&$Yin,$S.$(2013).$Categories$of$auditory$performance$and$speech$intelligibility$ratings$of$early@implanted$children$without$speech$training.$PloS%One,$8(1),$e53852.$doi:10.1371/journal.pone.0053852$


#

MOH CI REPORT 2009 2013 30JAN2016 REPORT TO PUBLISH 1 FEB 2016.pdf · National MOH CI Programme:...

Documents

Transcript of MOH CI REPORT 2009 2013 30JAN2016 REPORT TO PUBLISH 1 FEB 2016.pdf · National MOH CI Programme:...