Cochlear Implants : Influence of Microphone Aging and Dirtying

Hard of Hearing Clinical Trial

Official title:

Consequences of Aging and Dirtying of Microphones on the Performances of Cochlear Implants. Influence of Signal Coding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369718
• Other study ID #: 2014.873
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: February 14, 2017
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cochlear implant microphones are subject to aging and dirtying. The evolution may affect their efficiency. Several signal coding strategies are used in cochlear implants and their behaviour may be more or less affected by the aging process. In this work the investigators wish to assess this phenomenon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• French speaking persons (French native speakers; studies made in French)

• Ear, Nose and Throat (ENT) tests and check up for normal hearing listeners were normal (Hearing loss below 20 dBs for all frequencies situated in the 250-8000 Hz range)

• Not mentally retarded

Exclusion Criteria:

• Persons with tinnitus or headache

• Anxious people (taking psychiatric drugs)

• Mental alteration or mental retard

• Deafened persons or taking an ENT treatment (normal hearing listeners)

Related Conditions & MeSH terms

• Deafness
• Hard of Hearing
• Hearing Loss

Intervention

Other:
• Listening to 12 Fournier's lists of words
Patients will listen to words from Fournier's lists of words in presence of noise presented at different Signal to Noise Ratio (SNR). 6 disyllable words Fournier's lists are presented to the implantees: SNRs ranged from 0 to 15 decibels (dBs) (0; 3; 6; 9; 12; 15) ; the subjects repeat orally the words. Then microphone is cleaned and, again, 6 Fournier's lists are presented.
• Listening to 48 Fournier's lists of words
48 disyllable Fournier's lists of words are presented to the subjects (6 SNR*2 coding strategies*4 dirtying levels) and the subjects repeat orally the words. Dirtying levels will be simulated by sounds effects.

Locations

Country	Name	City	State
France	Pavillon ORL (U) - Hôpital Edouard Herriot	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of correct syllable recognition	French "spondee lists"	At day 1