A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI632 in Adults With Low-frequency Residual Hearing.

Cochlear4 sites in 1 country10 target enrollmentDecember 16, 2021

ConditionsSensorineural Hearing Loss Low-Frequency Residual Hearing

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sensorineural Hearing Loss
Sponsor: Cochlear
Enrollment: 10
Locations: 4
Primary Endpoint: To characterize hearing performance of the CI632 in an adult population under expanded indications for use.
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 16, 2021

End Date

June 16, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.