Hearing Implant Performance in Adults With Low-Frequency Residual Hearing

• Sponsor: Cochlear (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04741048
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.

Condition or Disease	Intervention/Treatment	Phase
Sensorineural Hearing Loss; Low-Frequency Residual Hearing	Device: CI624 Slim 20 Electrode	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 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 CI624 in Adults With Low-frequency Residual Hearing.
• Actual Study Start Date: Mar 8, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CI624 Slim 20 Electrode	Device: CI624 Slim 20 Electrode; Cochlear Ltd CI624 cochlear implant with Slim 20 Electrode

Outcome Measures

Primary Outcome Measures

1. Characterize hearing performance of the CI624. [14 months]

   Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent 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	Jacksonville Hearing and Balance	Jacksonville	Florida	United States	32256

Sponsors and Collaborators

• Cochlear

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cochlear
• ClinicalTrials.gov Identifier: NCT04741048
• Other Study ID Numbers: CAM5777
• First Posted: Feb 5, 2021
• Last Update Posted: Oct 6, 2021
• Last Verified: Sep 1, 2021

• 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 Oct 6, 2021