Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

September 5, 2022 updated by: Cochlear
Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant System (P130016) for individuals aged 18 years and older who present with bilateral residual low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss with limited benefit from appropriately fitted bilateral amplification. Additionally, the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is designed to support implantation via a round window (RW) approach while maintaining the same relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy

Study Type

Interventional

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Des Moines, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Eighteen years of age or older at the time of implantation
  2. Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, & 4000 Hz) of > 60dB HL.
  3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below
  4. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted
  5. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%
  6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation

Exclusion Criteria:

  1. Individuals aged greater than 75 years
  2. Duration of severe to profound hearing loss (above 2kHz) greater than 20 years
  3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  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 500 to 1000 Hz
  6. Deafness due to lesions of the acoustic nerve or central auditory pathway
  7. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease
  8. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
  9. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
  10. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implanted
Subjects will be implanted with the Hybrid SRW cochlear implant.
Device: Hybrid SRW cochlear implant
Subjects will be implanted with the Hybrid SRW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CNC (Consonant-nucleus-consonant) Words
Time Frame: 12 months
Two CNC( consonant-nucleus-consonant) Word lists (Peterson & Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Collaborators

University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2016

Primary Completion (Actual)

June 12, 2019

Study Completion (Actual)

June 12, 2019

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 23, 2015

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM 5630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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