Hybrid Cochlear Implants : Long-Term Results · 2018-04-03 · Hybrid Cochlear Implants : Long-Term...
Transcript of Hybrid Cochlear Implants : Long-Term Results · 2018-04-03 · Hybrid Cochlear Implants : Long-Term...
Hybrid Cochlear Implants: Long-Term Results
Bruce J Gantz, Camille Dunn, Marlan Hansen
The Iowa Cochlear Implant
Clinical Research Center Department of Otolaryngology
—Head and Neck Surgery The University of Iowa,
Iowa City, Iowa
Supported by grants from the NIH-NIDCD,
Iowa Lions Hearing Foundation
Consultant for: Cochlear Corporation
Advantages of Acoustic Hearing + Electric Hearing
– Preservation of Low Frequency Acoustic Hearing Enhances • Word Understanding in Quiet
– Average: 20% >CI only • Word Understanding in Noise • Spatial Hearing
– Ability to Localize Sound • Music and Melody Recognition • Quality of Sound
– Provides Temporal Fine Structure not available in current CI speech coding algorithms
0
20
40
60
80
100
1980~1985 1986~1990 1991~1995 1996~2000 2001~2005 2006~2010 2011~2014
Perc
ent C
orre
ct
Word Scores Over Time
HybridCNCBinauralCNCMonauralCNCMonauralNU6
5
2015
University of Iowa Post Lingual Adults N=>1800
2015
Hearing Preservation: Important Concepts
• Useful Hearing: “Functional Acoustic Hearing” – Must maintain better than 85-90dB in low frequencies* – If can not amplify with hearing aid: not useful – Not worthwhile to discuss the change or delta pre to post op if
do not maintain function hearing Frequency (Hz)
125 250 500 750 1000 1500 2000 3000 4000 6000 8000
Hear
ing
Thre
shol
d (d
B HL
)(A
NSI -
1989
)
-100
102030405060708090
100110120130
Average at 2, 3and 4k Hz
Functional Hearing
Non Functional Hearing
*Hornsby BWY, Ricketts TA. The effects of hearing loss on the contribution of high- and low frequency speech information to speech understanding. II. Sloping hearing loss. The Journal of the Acoustical Society of America. 2006;119(3):1752–1763.
Inclusion Criteria
>18 y/o Implant Ear 10-60% CNC Contra Lateral Ear Up to 80% CNC
Hybrid Clinical Trial FDA Selection Criteria
Frequency (Hz)125 250 500 750 1000 1500 2000 3000 4000 6000 8000
Hea
ring
Thr
esho
ld (d
B H
L)(A
NSI
- 19
89)
-100
102030405060708090
100110120130
Average at 2, 3and 4k Hz
US Hybrid FDA Clinical Trials:
• 164 Hybrid devices • 17 Centers in US (2000-14)
• 87 Hybrid S8 • 27 Hybrid S12 • 50 Hybrid L24
0
20
40
60
80
100
Preoperative 12 months Preoperative 12 months
Combined Hybrid
Perc
ent C
orre
ct
Hybrid Clinical Trial Studies CNC Words
S8 (6-12 mos;N=82)
Multi-Center Hybrid S12 (N=25) Iowa Hybrid S12 (N=13)
Hybrid L24 (12 mos;N=50)
N=157
0
20
40
60
80
100
S8 S12 L24 Unilateral Bilateral
Hybrid Implant Standard Implant
CN
C P
erce
nt C
orre
ct
HybridElectrodesversusStandardElectrodeCNCWords(IowaSubjects)
Combined Hybrid CI-Alone
Listening Conditions:
0
20
40
60
80
100
CN
C P
erce
nt C
orre
ct
Subject
Hybrid S12 CI-Only Hybrid L24 CI-Only Standard CI-Only
CI-Only CNC Words Different Devices
Hybrid L24 & S12: 6 Month Outcomes Groups 1 (Functional) & 2 (Non Functional)
Within Group subsets reveal similar results
Severe or Better Group 1 (n=33)
Profound/Total Group 2 (n=15) Severe or Better
Group 1 Profound/
Total Group 2
L24 S12 CNC Word Recognition
Hybrid 6 months Post Op N=25
Functional Hearing Functional Hearing
Speech Recognition in Multiple Talker Babble
-25
-20
-15
-10
-5
0
5
10
15
Long-Electrode Short-Electrode Normal
SRT-
in Ba
bble
(dB)
Group
-9 dB
-20
-15
-10
-5
0
5
10
15
20
0 20 40 60 80 100 120
SR
T in
dB
Average Low-frequency Thresholds in dB HL
n=20
n=11
r = 0.62 (p < .05)
Relationship between Preservation of Low Frequency Hearing and SRT in Babble
Benefits of Preserving Residual Hearing
* 5dB SNR improvement corresponds to increasing HINT scores from 43% to 76%
(Eddington et al., 1997)
• Acoustic Hearing Preservation
Important Issues
Profound Acoustic Hearing Loss Over Time
0
10
20
30
40
50
60
IA 12m IA 12m IA 18m IA 6m IA 6m
S8 S8 S12 S12 L24 L24 422-20 422-20 422-24 422-24
S8 IA S8 12m S12 IA S12 12m L24 IA L24 18m 422-20 IA 422-20 6m 422-24 IA 422-24 6m
17% 16%
44% 46%
56% Pe
rcen
t Pro
foun
d S8 N=83 S12 N=27 L24 N=50 422-20 N=27 422-24 N=26
3% 1%
10%
20%
45%
10 mm
16 mm 20 mm 24 mm
(% Non Functional Acoustic Hearing) N=213
6mo 33%
0
10
20
30
40
50
60
70
80
90
100
110
120
130
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Post-OpPT
AdB
HL
ImplantYear
IowaHybridPTAThresholdbyYearS8 (N=23) S12 (N=14) L24 (N=19)
*Red shapes indicate non-functional hearing with no AC use
US03-PRB
HighCurrentLevel
SteroidTreatm
ent
US23-HYB
89% Functional Hearing Preservation N=57 93% Functional Hearing Preservation N=53 (excluding over stim group)
• Long Term Results
Important Issues
Iowa Hybrid Acoustic PTA (.125-1k) Over Time
0
20
40
60
80
100
120
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Una
ided
PTA
(dB
HL)
N=24
Years Post Op
S8 S12
0
20
40
60
80
100
120
0 1 2 3 4 5 6 7
1
2
3
4
5
6
7
8N=13
0
20
40
60
80
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
N=24
Iowa Hybrid Combined CNC Word Score Over Time S8 S12
Years Post Op
Perc
ent C
orre
ct
0
20
40
60
80
100
0 1 2 3 4 5 6 7
1
2
6
9
1011121314
6mos
N=13
0 10 20 30 40 50 60 70 80 90
100 110 120 130
Pre 0.5 1 2 3 4-6 7-8 9-10 11-12 13-16
dB H
L
Years Post Implantation
Averaged PTA Over Time - Hybrid S8 and S12
S8
S12
S12N=1414141269S8N=2322 23 20 1616181614 6
0
20
40
60
80
100
Pre 0.5 1 2 4-6 7-8 9-10 11-12 13-16
CN
C P
erce
nt C
orre
ct
Years Post Implantation
S8 Combined
S8 Hybrid
S12 Combined
S12 Hybrid
S12N=141413108S8N=2323211517151516 14
6
Averaged CNC Words Over Time - Hybrid S8 and S12 Combined and Hybrid Conditions (Iowa)
1. Long Term Stability of Results – over 16+ years • 90% using A+E • 86% > 60% CNC word understanding
(combined condition)
Hybrid S8 & S12 (10mm) Electrode
Iowa Hybrid S Subjects: N=37
• “Functional” acoustic hearing can be maintained in most
subjects with hearing preservation electrodes at initial activation (93%)
• 13-51% lose “Functional” hearing over time, majority lose hearing after activation
• Shorter electrodes have better preservation rates • Mechanisms: Trauma, Excitotocity, Other • In fibrosis case: apical hair cells and neurons
preserved!
• Central auditory plasticity can accommodate to place-pitch shift
• “Functional” acoustic hearing and improved speech perception scores can be preserved for over 16 years using A + E
• Performance with CI quite variable for all lengths of electrodes
Summary
Hybrid FDA Multicenter Trial Centers • FDA Clinical Trial: Hybrid S8
University of Iowa* New York University*
University of Miami* Indiana University* House Ear Institute* University of Texas Southwestern* Kansas City Ear Institute* California Ear Institute* Dallas Otolaryngology Associates* Mayo Clinic Rochester* University of Washington* UCSF* Denver Ear Associates* Center Hearing & Balance St Louis* Arizona Ear Center* University of Florida*
FDA Trial: Hybrid S12 University of Iowa University of Washington UCSF University of Miami Dallas Otolaryngology Assoc Cleveland Clinic FDA Trial: Hybrid L24 New Your University Mayo Clinic University of Iowa House Ear Institute Northwestern University Kansas City Ear University of Cincinnati Center Hearing and Balance St
Louis Washington University