Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

Sensorineural Hearing Loss Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741009
• Other study ID #: CAM5776
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Cochlear
• Contact: Paul Reinhart
• Phone: 612-456-1621
• Email: preinhart[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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 greater than or equal to 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.

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Low-Frequency Residual Hearing
• Sensorineural Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	Midwest Ear Institute	Kansas City	Missouri
United States	New York University	New York	New York
United States	Georgetown University	Washington	District of Columbia
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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