Status:
COMPLETED
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
Lead Sponsor:
Cochlear
Conditions:
Sensorineural Hearing Loss
Low-Frequency Residual Hearing
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet i...
Eligibility Criteria
Inclusion
- 18 years-of-age or older at the time of surgery.
- Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
- Pure-tone average (PTA) (0.5k, 1k, 2k Hz) \> 30 dB HL in the contralateral ear.
- CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
- English spoken as a primary language.
- Willing and able to provide written informed consent.
Exclusion
- Individuals greater than or equal to 70 years at the time of surgery.
- Duration of severe to profound sensorineural hearing loss \> 20 years per self-report.
- Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
- Hearing loss of neural or central origin.
- Diagnosis of Auditory Neuropathy.
- Active middle-ear infection.
- Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).
- Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04741009
Start Date
December 16 2021
End Date
June 16 2025
Last Update
July 18 2025
Active Locations (4)
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1
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
2
Midwest Ear Institute
Kansas City, Missouri, United States, 64111
3
Cleveland Clinic
Cleveland, Ohio, United States, 44106
4
University Hospitals
Cleveland, Ohio, United States, 44106