N/A
N=40
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT03052920 ↗Enrolled (actual)
40
Serious AEs
20.0%
Results posted
Oct 2021
Primary outcome: Primary: Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet — 0.09; 0.53; 0.44 percentage of words correct — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cochlear implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet |
0.09; 0.53; 0.44 | <0.001 sig |
| PRIMARY Change in Poor Ear Alone Soundfield Thresholds |
54.95; 26.54; 28.41 | <0.001 sig |
| SECONDARY Change in Sound Localization |
45.05; 39.07; 5.99 | <0.05 sig |
| SECONDARY Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) |
66.81; 83.06; 16.25 | <0.001 sig |
| SECONDARY Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) |
64.39; 71.42; 7.03 | <0.05 sig |
| SECONDARY Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear |
6.61; 4.06; 2.56 | <0.01 sig |
| SECONDARY Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone |
13.97; 64.86; 50.89 | <0.001 sig |
| SECONDARY Change in Hearing Handicap Inventory (HHIE) |
0.67; 0.46; 0.21 | <0.001 sig |
| SECONDARY Change in Health Utility Index (HUI3) Ratings |
0.51; 0.66; 0.15 | <0.001 sig |
| SECONDARY Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant |
3.42; 5.46; 2.03 | <0.001 sig |
| SECONDARY Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant |
3.37; 5.37; 2.00 | <0.001 sig |
| SECONDARY Change in Satisfaction With Amplification in Daily Use (SADL) |
4.88; 5.36; 0.48 | <0.05 sig |
| SECONDARY Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) |
2.27; 3.50; 1.22 | <0.001 sig |
| SECONDARY Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant |
55.96; 22.98; 32.98 | <0.001 sig |
| SECONDARY Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear |
1.82; 0.42; 1.40 | <0.05 sig |
Summary
This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- English as the native language
- Have a desire for functional binaural hearing
- Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary
- Willingness to comply with all study requirements
- Ability to provide informed consent
- Poor ear (ear to be implanted):
- Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)
- Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%
- Duration of SPHL ≥ 6 months
- Onset of hearing loss ≥ 6 years of age
- Better ear:
- PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL
- Currently using a HA
- Aided word recognition score (CNC Word Test) at 60 dB SPL > 40%
- Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies
Exclusion Criteria
- Medical condition that contraindicates surgery
- Actively using an implantable device in the ear to be implanted
- Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
- Hearing loss of neural or central origin
- Unrealistic expectations related to the benefits and limitations of cochlear implantation
- Unwillingness or inability to comply with all investigational requirements
Data sourced from ClinicalTrials.gov (NCT03052920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.