NCT02309541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

December 2, 2014

Last Update Submit

October 6, 2017

Conditions

Hearing Loss

Keywords

middle ear implantfeedback managerSound quality

Outcome Measures

Primary Outcomes (4)

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

    1 month

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

    2 months

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

    3 months

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

    4 months

Secondary Outcomes (4)

  • Improvement in speech understanding assessed via speech audiometry in noise

    1 month

  • Improvement in speech understanding assessed via speech audiometry in noise

    2 months

  • Improvement in speech understanding assessed via speech audiometry in noise

    3 months

  • Improvement in speech understanding assessed via speech audiometry in noise

    4 months

Study Arms (2)

Firmware N

EXPERIMENTAL

New feedback canceller algorithm

Device: feedback canceller algorithm (Firmware)

Firmware R

ACTIVE COMPARATOR

Current feedback canceller algorithm (reference)

Device: feedback canceller algorithm (Firmware)

Interventions

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.

Firmware NFirmware R

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unwillingness or inability to comply with all of the investigational requirements
  • additional handicaps that would prevent or restrict participation in the audiological evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Nord

Marseille, Bouches-du-Rhône, 13915, France

Location

Hôpital Edouard Herriot

Lyon, Rhône, 69003, France

Location

CHU Lyon Sud

Pierre-Bénite, Rhône, 69495, France

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stéphane Tringali, Prof

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 5, 2014

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

FR(3)