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Clinical Trials/NCT05956808
NCT05956808
Completed
Not Applicable

Phonak Behind-The-Ear Quality Evaluation

Sonova AG1 site in 1 country7 target enrollmentJuly 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss, Sensorineural
Sponsor
Sonova AG
Enrollment
7
Locations
1
Primary Endpoint
Speech in Noise Test
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Detailed Description

Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Registry
clinicaltrials.gov
Start Date
July 17, 2023
End Date
August 16, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
  • 18+ years old
  • Good written and spoken English language skills
  • Able to fill in a questionnaire conscientiously
  • Experienced hearing aid user
  • Able to produce a reliable hearing test result
  • Able to describe listening impressions/experiences and the use of the hearing aids

Exclusion Criteria

  • Not willing to test the hearing aids
  • Has auricle deformities that prevents secure placement of the hearing aids
  • Has limited mobility and is not able to attend the appointments
  • Not willing to wear the hearing aids for at least 8 hours per day
  • Known hypersensitivity or allergy with synthetic materials
  • Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
  • Hints of psychological problems
  • Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)

Outcomes

Primary Outcomes

Speech in Noise Test

Time Frame: Day 14 of the study

Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.

Subjective measure of listening effort

Time Frame: Day 14 of the study

A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.

Study Sites (1)

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