Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

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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

April 30, 2021

Completion Date

January 2023

Primary Completion Date

January 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

March 2021