Evaluation of New Feedback Canceller for Carina™ Implant

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309541
• Other study ID #: CFRA-A01/CEL5584
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: October 6, 2017
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon	Rhône
France	Hôpital Nord	Marseille	Bouches-du-Rhône
France	CHU Lyon Sud	Pierre-Bénite	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire		1 month
Primary	Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire		2 months
Primary	Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire		3 months
Primary	Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire		4 months
Secondary	Improvement in speech understanding assessed via speech audiometry in noise		1 month
Secondary	Improvement in speech understanding assessed via speech audiometry in noise		2 months
Secondary	Improvement in speech understanding assessed via speech audiometry in noise		3 months
Secondary	Improvement in speech understanding assessed via speech audiometry in noise		4 months