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Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

Sponsor
Cochlear (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04741009
Collaborator
(none)
15
Enrollment
4
Locations
1
Arm
28.5
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CI632 Slim Modiolar Electrode
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
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.
Actual Study Start Date :
Dec 16, 2021
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CI632 Slim Modiolar Electrode

Device: CI632 Slim Modiolar Electrode
Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode

Outcome Measures

Primary Outcome Measures

  1. To characterize hearing performance of the CI632 in an adult population under expanded indications for use. [14 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 18 years-of-age or older at the time of surgery.

  2. 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.

  3. Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear.

  4. CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.

  5. English spoken as a primary language.

  6. Willing and able to provide written informed consent.

Exclusion Criteria:

  1. Individuals older than 70 years at the time of surgery.

  2. Duration of severe to profound sensorineural hearing loss > 20 years per self-report.

  3. Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.

  4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.

  5. 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.

  6. Hearing loss of neural or central origin.

  7. Diagnosis of Auditory Neuropathy.

  8. Active middle-ear infection.

  9. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.

  10. 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.

  11. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.

  12. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.

  13. Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).

  14. Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.

  15. Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UMass Memorial Medical Center Worcester Massachusetts United States 01655
2 New York University New York New York United States 10016
3 Cleveland Clinic Cleveland Ohio United States 44106
4 University Hospitals Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Cochlear

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cochlear
ClinicalTrials.gov Identifier:
NCT04741009
Other Study ID Numbers:
  • CAM5776
First Posted:
Feb 5, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Mar 29, 2022