Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

NCT04741009 | Completed FDA Device

• 1 other identifier: CAM5776
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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 inclusion criteria.

Conditions

Sensorineural Hearing Loss; Low-Frequency Residual Hearing

Outcome Measures

Primary Outcomes (1)

• To characterize hearing performance of the CI632 in an adult population under expanded indications for use.

  To characterize hearing performance of the CI632 using CNC word recognition in quiet scores with percentage correct words.

  14 months

Study Arms (1)

CI632 Slim Modiolar Electrode

EXPERIMENTAL

Device: CI632 Slim Modiolar Electrode

Interventions

CI632 Slim Modiolar Electrode DEVICE

Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode

CI632 Slim Modiolar Electrode

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (4)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Midwest Ear Institute

Kansas City, Missouri, 64111, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: February 5, 2021
• Study Start: December 16, 2021
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: July 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)