Evaluation of New Feedback Canceller for Carina™ Implant

Study Overview
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Brief Summary
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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.

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

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: feedback canceller algorithm (Firmware)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Firmware N<br>New feedback canceller algorithm | Device: feedback canceller algorithm (Firmware)<br>* 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.<br>|
| Active Comparator: Firmware R<br>Current feedback canceller algorithm (reference) | Device: feedback canceller algorithm (Firmware)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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middle ear implant, feedback manager, Sound quality