MedPath

A Pediatric Comparison of Remote Microphone Technologies

Not Applicable
Completed
Conditions
Hearing Loss
Interventions
Device: Phonak Roger TouchScreen Microphone
Device: Phonak Partner Mic
Registration Number
NCT06564701
Lead Sponsor
Sonova AG
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Lab and Home TrialPhonak Roger TouchScreen MicrophoneParticipants who complete the lab testing, and who are able to use both devices during a field trial period in school
Lab and Home TrialPhonak Partner MicParticipants who complete the lab testing, and who are able to use both devices during a field trial period in school
Experimental No Field TrialPhonak Roger TouchScreen MicrophoneParticipants who are only able to complete the lab testing
Experimental No Field TrialPhonak Partner MicParticipants who are only able to complete the lab testing
Primary Outcome Measures
NameTimeMethod
Speech Intelligibility score using the AZ Bio Sentence Test-teacher conditionOne 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 conditionOne 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 Outcome Measures
NameTimeMethod
Listening Fatigue using the Vanderbilt Fatigue Scale for ChildrenTwo days (Visit 2 and Visit 3)

Ten questions related to fatigue, answers rank from 1 (never) to 5 (almost always). Total scores can range from 10 to 50, with higher scores indicating more self-perceived fatigue.

Subjective Preferences of participantsTwo days (Visit 1 following the lab testing, and Visit 3, following the field trial)

Participants will be asked to rank their preference for the microphone systems using a Likert type of rating scale (1-5), where a lower score (\<3) would indicate preference for the partner mic and a higher score (\>3) will indicate preference for the Roger Touchscreen.

Trial Locations

Locations (1)

Hearts for Hearing

🇺🇸

Oklahoma City, Oklahoma, United States

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