Evaluation of New Feedback Canceller for Carina™ Implant

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: feedback canceller algorithm (Firmware)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309541

CFRA-A01/CEL5584

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

12 participants in 2 patient groups

Firmware N

Experimental group

Description:

New feedback canceller algorithm

Treatment:

Device: feedback canceller algorithm (Firmware)

Firmware R

Active Comparator group

Description:

Current feedback canceller algorithm (reference)

Treatment:

Device: feedback canceller algorithm (Firmware)