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Completed

NCT Number: NCT02309541

Evaluation of New Feedback Canceller for Carina™ Implant

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Nord, Marseille, Bouches-du-Rhône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

feedback canceller algorithm (Firmware)

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.

Primary outcomes

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

    Time frame: 1 month

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

    Time frame: 2 months

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

    Time frame: 3 months

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

    Time frame: 4 months

Secondary outcomes

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

    Time frame: 1 month

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

    Time frame: 2 months

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

    Time frame: 3 months

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

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2014
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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