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Hearing Implant Performance in Adults With Low-Frequency Residual Hearing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04741048
Recruitment Status : Withdrawn (Sponsor decided to cancel the study prior to any subjects being enrolled/consented due to the lack of CMS coverage and an internal staffing shortage.)
First Posted : February 5, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Cochlear

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 8, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CI624 Slim 20 Electrode Device: CI624 Slim 20 Electrode
Cochlear Ltd CI624 cochlear implant with Slim 20 Electrode


Outcome Measures
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Primary Outcome Measures :
  1. Characterize hearing performance of the CI624. [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741048


Locations
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United States, Florida
Jacksonville Hearing and Balance
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
Cochlear
More Information
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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT04741048    
Other Study ID Numbers: CAM5777
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases