Evaluation of New Feedback Canceller for Carina™ Implant
Not Applicable
Completed
- Conditions
- Hearing Loss
- Registration Number
- NCT02309541
- Lead Sponsor
- Cochlear
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire 4 months
- Secondary Outcome Measures
Name Time Method Improvement in speech understanding assessed via speech audiometry in noise 4 months
Trial Locations
- Locations (3)
Hôpital Nord
🇫🇷Marseille, Bouches-du-Rhône, France
Hôpital Edouard Herriot
🇫🇷Lyon, Rhône, France
CHU Lyon Sud
🇫🇷Pierre-Bénite, Rhône, France
Hôpital Nord🇫🇷Marseille, Bouches-du-Rhône, France