Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

Completed · Not applicable

Conditions studied: Sensorineural Hearing Loss, Low-Frequency Residual Hearing

In brief

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 inclusion criteria.

Key facts

Study ID

NCT04741009

Run by

Cochlear

People needed

10

Starts

2021-12-16

Expected to finish

2025-06-16

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Midwest Ear Institute — Kansas City, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University Hospitals — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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