Hearing Loss
Conditions
Keywords
middle ear implant, feedback manager, Sound quality
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.
Interventions
DEVICEfeedback 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.
Sponsors
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in speech understanding assessed via speech audiometry in noise | 1 month |
Countries
France
Outcome results
None listed