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Clinical Trials/NCT04357704
NCT04357704
Withdrawn
Not Applicable

Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.

Oticon Medical0 sitesApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss, Cochlear
Sponsor
Oticon Medical
Primary Endpoint
speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue
Status
Withdrawn
Last Updated
9 months ago

Overview

Brief Summary

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

Detailed Description

Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
September 1, 2019
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Fluent in local language
  • Normal hearing listener:
  • pure tone threshold \> 25dB from 125Hz to 12kHz
  • Cochlear implant recipient
  • bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
  • Digisonic SP® cochlear implants user

Exclusion Criteria

  • binaural sensitivity threshold \< 1000µs

Outcomes

Primary Outcomes

speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue

Time Frame: day 0

SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.

Secondary Outcomes

  • speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners(day 0)
  • ITD sensitivity in bilateral cochlear implant user(day 0)
  • Preferred jitter in bilateral cochlear implant user(day 0)

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