N/A
N=44
Expanded Indications in the Adult Cochlear Implant Population
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT03236909 ↗Enrolled (actual)
44
Serious AEs
47.7%
Results posted
Jun 2025
Primary outcome: Primary: Change in Percent Correct on Word Recognition in Quiet in Implanted Ear — 25.6 Change in percentage points
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Med-El Corporation
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Correct on Word Recognition in Quiet in Implanted Ear |
25.6 | — |
| PRIMARY Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear |
24.1 | — |
| SECONDARY Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition |
-29.5 | — |
| SECONDARY Number of Participants Experiencing an Adverse Device Effect (ADE) |
31 | — |
| SECONDARY Number of Participants With Residual Low-frequency Hearing |
3; 24; 4; 12 | — |
| SECONDARY Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition |
1.9 | — |
Summary
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.
Eligibility Criteria
Inclusion Criteria
- Adults, 18 years of age or older at the time of implantation
- Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
- Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
- Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
- CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
- Evidence of appropriately fit hearing aids as determined by the audiologist
- Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
- Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
- If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
- Fluent in English
- No radiological contraindications
- Ability to undergo general anesthesia
- Appropriate motivation and expectation levels
- Stated willingness to comply with all study procedures for the duration of the study
Exclusion Criteria
- Evidence that hearing loss is retrocochlear in origin
- Active middle ear infection
- Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
- History of prior use of a hearing implant
Data sourced from ClinicalTrials.gov (NCT03236909). 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.