Evaluation of New Feedback Canceller for Carina™ Implant

October 6, 2017 updated by: Cochlear

Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device

The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • France
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13915
        • Hopital Nord
    • Rhône
      • Lyon, Rhône, France, 69003
        • Hopital Edouard Herriot
      • Pierre-Bénite, Rhône, France, 69495
        • CHU Lyon Sud

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • successfully implanted with a commercial available CE-labelled implant device, resulting in measurable open set speech understanding
  • native speaker in the language used to assess their clinical performance, i.e. French

Exclusion Criteria:

  • unwillingness or inability to comply with all of the investigational requirements
  • additional handicaps that would prevent or restrict participation in the audiological evaluations

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Firmware N
New feedback canceller algorithm
Device: feedback canceller algorithm (Firmware)
The study consists of two phases. Phase 1: optimization of parameters of new feedback canceller algorithm. Phase 2: comparison of new and reference feedback canceller algorithms.
Active Comparator: Firmware R
Current feedback canceller algorithm (reference)
Device: feedback canceller algorithm (Firmware)
The study consists of two phases. Phase 1: optimization of parameters of new feedback canceller algorithm. Phase 2: comparison of new and reference feedback canceller algorithms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame: 1 month
1 month
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame: 2 months
2 months
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame: 3 months
3 months
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame: 1 month
1 month
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame: 2 months
2 months
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame: 3 months
3 months
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Cochlear

Investigators

  • Principal Investigator: Stéphane Tringali, Prof, Hospices Civils de Lyon

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 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFRA-A01/CEL5584

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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