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Evaluation of New Feedback Canceller for Carina™ Implant

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
feedback canceller algorithm (Firmware)
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring middle ear implant, feedback manager, Sound quality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Nord
  • Hôpital Edouard Herriot
  • CHU Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Firmware N

Firmware R

Arm Description

New feedback canceller algorithm

Current feedback canceller algorithm (reference)

Outcomes

Primary Outcome Measures

Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire

Secondary Outcome Measures

Improvement in speech understanding assessed via speech audiometry in noise
Improvement in speech understanding assessed via speech audiometry in noise
Improvement in speech understanding assessed via speech audiometry in noise
Improvement in speech understanding assessed via speech audiometry in noise

Full Information

First Posted
December 2, 2014
Last Updated
October 6, 2017
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT02309541
Brief Title
Evaluation of New Feedback Canceller for Carina™ Implant
Official Title
Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
middle ear implant, feedback manager, Sound quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Firmware N
Arm Type
Experimental
Arm Description
New feedback canceller algorithm
Arm Title
Firmware R
Arm Type
Active Comparator
Arm Description
Current feedback canceller algorithm (reference)
Intervention Type
Device
Intervention Name(s)
feedback canceller algorithm (Firmware)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame
1 month
Title
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame
2 months
Title
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame
3 months
Title
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame
1 month
Title
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame
2 months
Title
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame
3 months
Title
Improvement in speech understanding assessed via speech audiometry in noise
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Tringali, Prof
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Nord
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13915
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69003
Country
France
Facility Name
CHU Lyon Sud
City
Pierre-Bénite
State/Province
Rhône
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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Evaluation of New Feedback Canceller for Carina™ Implant

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