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Clinical Trials/NCT06564701
NCT06564701
Completed
N/A

A Pediatric Comparison of Remote Microphone Technologies

Sonova AG1 site in 1 country25 target enrollmentAugust 5, 2024
ConditionsHearing Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Sonova AG
Enrollment
25
Locations
1
Primary Endpoint
Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition
Status
Completed
Last Updated
last year

Overview

Brief Summary

Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone.

Detailed Description

Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone. The simulated classroom environment will include a teacher condition, in which speech is presented from a distance in front of the participant, and a small-group condition, in which speech is presented randomly from three different speakers around the participant. Both conditions will have diffuse background noise, and the various SNR (Signal to Noise Ratio) levels will be tested. Subjective preference and fatigue questionnaires will also be collected from the participants after the use of each transmitter.

Registry
clinicaltrials.gov
Start Date
August 5, 2024
End Date
January 16, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy middle and outer ear
  • Mild, moderate or moderate-severe binaural sensorineural hearing loss
  • Minimum AZ Bio score of 70% at 60 dB in quiet
  • Experienced hearing aid users (6+ months)
  • Able to read and follow directions
  • English speakers with ability to communicate easily

Exclusion Criteria

  • Active middle ear infection
  • Temporary or unilateral hearing loss
  • Unable to follow verbal directions
  • Unable to communicate easily
  • Unable to tolerate the physical fit of the hearing aids

Outcomes

Primary Outcomes

Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition

Time Frame: One day (Visit 1)

Sentences are presented from a front speaker located 8.5 feet away from participant. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.

Speech Intelligibility score using the AZ Bio Sentence Test- small group condition

Time Frame: One day (Visit 1)

Sentences are presented randomly from three different speakers, located around a small table with the participant, simulating a small group at a table. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.

Secondary Outcomes

  • Listening Fatigue using the Vanderbilt Fatigue Scale for Children(Two days (Visit 2 and Visit 3))
  • Subjective Preferences of participants(Two days (Visit 1 following the lab testing, and Visit 3, following the field trial))

Study Sites (1)

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