EFFICACY of OAE/ABR PROTOCOL in IDENTIFYING

HEARING LOSS

National Early Hearing Detection and Intervention Meeting

Washington, D.C.February 20, 2004

Funded by the Centers for Disease Control and

Prevention

under a Cooperative Agreement with:

The Association of Teachers of Preventive Medicine

with a sub-agreement to:The University of Hawai`i

CORE STAFF

Jean Johnson DrPH - Principal Investigator

Karl White, PhD - Research Coordinator

Judith E. Widen, PhD - Diagnostic Evaluation Coordinator

SITE CO-PRINCIPAL INVESTIGATORS

Judith Gravel, PhD: Jacobi Medical Center (Bronx, New York)

Michele James-Trychel, MEd: Arnold Palmer Hospital (Florida)

Antonia B. Maxon, PhD: Lawrence & Memorial (Connecticut)

Teresa Kennalley, MA: Via Christi Regional Medical Center (Kansas)

Lynn Spivak, PhD: Long Island Jewish Health System (New York)

Maureen Sullivan-Mahoney, MA: Good Samaritan Hospital (Ohio)

Betty Vohr, MD: Women & Infants Hospital (Rhode Island)

Yusnita Weirather, MA: Kapi`olani Medical Center (Hawai`i)

CDC CONSULTANTS

Krista Biernath, MD Technical Advisor

Lee Ann Ramsey, BBA, GCPH

Program Advisor

Background:

Conclusion of the National Institutes of Health (NIH) Consensus Panel:

“ (3) the preferred model for screening should begin with an evoked otoacoustic emissions test and should be followed by an auditory brainstem response test for all infants who fail the evoked otoacousticemissions test.”

NIH Consensus Statement March 3, 1993

RESEARCH QUESTION

Does this two-stage procedure

miss

a significant number of babies with

a congenital hearing loss?

CRITERIA for SELECTION of CRITERIA for SELECTION of BIRTHING SITESBIRTHING SITES

2,000 or more births per year

Established newborn hearing screening program with at least six month history of success

Historical refer rates of less than 10% for OAE and 4% for ABR

Success in obtaining follow-up on 90% or more of referrals

Ethnic and socio-economic distribution similar to US population

PROJECTED SAMPLE SIZE

53,889 Annual Births

1,616 Eligible (Refer on OAE, Pass ABR)

1,500 Consent to participate; and family speaks either English or Spanish

1,000 Babies return for complete diagnostic testing

BIRTHING CENTERS 2001 - 2003 BIRTH CENSUS

Name of Hospital Enrollment Period Number of Births Arnold Palmer 06/01/2001 – 12/31/2002 16,608

Good Samaritan 06/01/2001 – 01/31/2003 9,393

Jacobi Medical 09/20/2001 – 01/31/2003 4,747

Lawrence & Memorial 06/27/2001 – 03/31/2003 1,380

Long Island Jewish 05/01/2001 – 01/31/2003 10,424

Kapi`olani Medical 05/15/2001 – 01/31/2003 9,252

Via Christi 05/01/2001 – 01/31/2003 6,217

Women & Infants 05/01/2001 – 01/31/2003 16,623

Huntington 05/01/2001 – 01/31/2003 3,384

Northshore 05/01/2001 – 01/31/2003 10,224

Total Birth Census for Enrollment Period 88,252

PROCESSPROCESS

Eligible babies identified following newborn hearing screening.

Parents contacted and research study explained.

Consent obtained from families. Enrollment data collected. Contact maintained with family at 2, 4, &

6 months of age via post cards.

Baby seen for audiological diagnostic evaluation between 7-9 months of adjusted age.

DATA BEING COLLECTED

Birthdate Bronchio-pulmonary Dsplasia

Gender Mechanical Ventilation >7 Days

Birth Weight ECMO

Gestational Age Number of Children in Home

APGAR Scores Number of Adults in Home

Days in NICU Total Household Income

Malformations of the Head and Neck Child’s Race/Ethnicity

Syndrome Associated with Hearing Loss Health Insurance

In-utero Infections Family History of Hearing Loss

CURRENT ENROLLMENT STATUS

1,572 Infants Enrolled as of September 2003

Exceeded Target Enrollment

PERCENTAGE of CURRENT SAMPLE at EACH

PARTICIPATING HOSPITAL

2 5 1280

146

281

361429

512

603679

750810

873933

9871,043

1,117

1,214

1,3021,377

1,4471,517

1,5601,561

0

200

400

600

800

1000

1200

1400

1600

1800

Jan-

01

Mar

-01

May

-01

Jul-0

1

Sep-0

1

Nov-0

1

Jan-

02

Mar

-02

May

-02

Jul-0

2

Sep-0

2

Nov-0

2

Jan-

03

Month & Year of Birth

Cu

mu

lati

ve F

req

uen

cy

CUMULATIVE ENROLLMENTAs of September 2003Goal: 1,500 infants

CHILD ETHNICITY(Percentage of Current Sample)

HEALTH INSURANCE STATUS

(percentage of current sample)

6.9

3.6

10.1 10.8 9.8

12.9

31.6

0

5

10

15

20

25

30

35

<5000$ 5,000 -9,999$

10,000 -19,999$

20,000 -29,999$

30,000 -39,999$

40,000 -49,999$

50,000 and >

Income in baby's household/year

Per

cen

tAnnual Income in Baby’s

Household

AUDIOLOGICAL DIAGNOSTIC EVALUATION

Visual reinforcement audiometry

Tympanometry

EOAE – either TOAE or DPOAE

VRA PROTOCOLVRA PROTOCOL

Well-defined, detailed Well-defined, detailed protocolprotocol

Responses at 500, 1K, 2K, Responses at 500, 1K, 2K, 4K Hz4K Hz

Response levels of 15 dB HLResponse levels of 15 dB HL

885 Diagnostic EvaluationsCompleted

DIAGNOSTIC EVALUATIONS

1847

101137

185224

268308

337366

401435

478518

555

602

659

716758

793818

846866 874 883 885

0

100

200

300

400

500

600

700

800

900

1000

Behavioral Evaluations by Month Completed

Cu

mu

lati

ve

Fre

qu

ency

Behavioral Evaluations as of January 29, 2004

DIAGNOSTIC EVALUATIONS(percentage completed at each participating

hospital)

EXPANDED STUDY

Comparison Group: Refer/Refer Babies who failed both OAE and ABR

and were referred for a diagnostic evaluation

Same enrollment data

Results of audiological diagnostic evaluations

VALUE of EXPANDED VALUE of EXPANDED STUDYSTUDY

Enables study to determine what Enables study to determine what proportion that babies with a hearing proportion that babies with a hearing loss from the refer/pass group represent loss from the refer/pass group represent of all babies identified with hearing loss of all babies identified with hearing loss in the sample cohort.in the sample cohort.

Additional data provides an accurate Additional data provides an accurate estimate of the proportion of all babies estimate of the proportion of all babies with congenital hearing loss who are with congenital hearing loss who are being missed by the two-stage OAE/ABR being missed by the two-stage OAE/ABR protocol.protocol.

3 5 11 3163 81

112145

177209

239272291

312337

367374389422

443484

529557

583

0

100

200

300

400

500

600

700

Jan-

01

Mar-

01

May

-01

Jul-0

1

Sep-01

Nov-01

Jan-

02

Mar-

02

May

-02

Jul-0

2

Sep-02

Nov-02

Jan-

03

Month & Year of Birth

Cu

mu

lati

ve F

req

uen

cy

ATPM EXPANDED STUDY:Cumulative EnrollmentAs of January 2004

Number of Inactivated Infants Number of Inactivated Infants by Monthby Month

152

214237

277 278

322 330346 353

377

0

50

100

150

200

250

300

350

400

Jan Feb Mar April May June July Aug Sep Oct

Months

Nu

mb

er o

f in

act

iva

ted

in

fan

ts

REVISED TIME LINEREVISED TIME LINE

Enrolled babies through January Enrolled babies through January 2003.2003.

Complete evaluations by January Complete evaluations by January 2004.2004.

Investigators analyze data in March Investigators analyze data in March 2004.2004.

Present results in May 2004.Present results in May 2004.

Are we missing Are we missing babies with babies with

existing existing screening screening

equipment? equipment?

If so how many If so how many and of what type? and of what type?

What is the What is the significance of significance of variable pass-variable pass-

refer rates refer rates associated with associated with

different different screening screening devices devices

(AOAE and (AOAE and AABR)?AABR)?

What Kind of Babies will be found

Congenital hearing loss

Late-onset loss

Study Design Improvements

Diagnostic ABR for all babies who failed OAE regardless of AABR result

Larger sample size

Would the follow-Would the follow-up of high- risk up of high- risk babies improve babies improve

the sensitivity of the sensitivity of the screening the screening

tests in detecting tests in detecting mild forms of mild forms of hearing loss?hearing loss?

What is the cost What is the cost effectiveness of effectiveness of

different different screening screening protocols?protocols?

Does ASSR have Does ASSR have a role in the a role in the

screening and screening and assessment of assessment of

infants?infants?

Auditory Auditory NeuropathyNeuropathy

How many of the babies in How many of the babies in our sample who passed AOAE our sample who passed AOAE would have been identified as would have been identified as

at risk for AN if we had at risk for AN if we had tested all with AABR?tested all with AABR?

Should we use different Should we use different screening protocols in the screening protocols in the

NICU than WBN?NICU than WBN?