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Evaluation of New Feedback Canceller for Carina™ Implant

NCT ID: NCT02309541

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Hearing Loss

Keywords

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middle ear implant feedback manager Sound quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Firmware N

New feedback canceller algorithm

Group Type EXPERIMENTAL

feedback canceller algorithm (Firmware)

Intervention Type DEVICE

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.

Firmware R

Current feedback canceller algorithm (reference)

Group Type ACTIVE_COMPARATOR

feedback canceller algorithm (Firmware)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Tringali, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Nord

Marseille, Bouches-du-Rhône, France

Site Status

Hôpital Edouard Herriot

Lyon, Rhône, France

Site Status

CHU Lyon Sud

Pierre-Bénite, Rhône, France

Site Status

Countries

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France

Other Identifiers

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CFRA-A01/CEL5584

Identifier Type: -

Identifier Source: org_study_id