Brief Title
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
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.
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.
Study Type
Interventional
Primary Outcome
To characterize hearing performance of the CI632 in an adult population under expanded indications for use.
Condition
Sensorineural Hearing Loss
Intervention
CI632 Slim Modiolar Electrode
Study Arms / Comparison Groups
CI632 Slim Modiolar Electrode
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
15
Start Date
December 1, 2021
Completion Date
September 1, 2023
Primary Completion Date
September 1, 2023
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, 422-325-4171, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04741009
Organization ID
CAM5776
Responsible Party
Sponsor
Study Sponsor
Cochlear
Study Sponsor
, ,
Verification Date
July 2021