Clinical Trial: Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Brief Summary: The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.

Detailed Summary:

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.

The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.


Sponsor: Phonak AG, Switzerland

Current Primary Outcome:

  • Objective measurement of speech intelligibility related to the intervention. [ Time Frame: 5 years ]
    SNR (speech to noise ratio) in decibel.
  • Objective measurement of the transfer function related to the intervention. [ Time Frame: 5 years ]
    REM (real ear measurement) in decibel.
  • Objective measurement from the position of the outer ear related to the test subject. [ Time Frame: 5 years ]
    Measurement in degree.
  • Objective measurement from the size of the outer ear related to the test subject. [ Time Frame: 5 years ]
    Measurement in micron.
  • Objective measurement of humidity in the ear canal related to the test subject and the intervention. [ Time Frame: 5 years ]
    Measurement in percent.
  • Objective measurement of temperature in the ear canal related to the test subject and the intervention. [ Time Frame: 5 years ]
    Measurement in degree centigrade.


Original Primary Outcome: Same as current

Current Secondary Outcome: Subjective rating of the intervention via questionnaire. [ Time Frame: 5 years ]

Ordinal scale


Original Secondary Outcome: Same as current

Information By: Phonak AG, Switzerland

Dates:
Date Received: August 19, 2015
Date Started: January 2017
Date Completion: December 2020
Last Updated: October 24, 2016
Last Verified: October 2016