N/A
N=10
Benefits of Assistive Listening Device for Speech Intelligibility
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05072470 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Speech Intelligibility in Noise — 58; 80; 27; 50 percentage of words correctly repeated — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Roger microphone (Device); Phonak Audeo hearing aid (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Intelligibility in Noise |
58; 80; 27; 50; 80; 87 | <0.01 sig |
Summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
Eligibility Criteria
Inclusion Criteria
- adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
- experienced hearing aid users
- symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
- good written and spoken English language skills
- healthy outer ear as confirmed by otoscopy
Exclusion Criteria
- contradictions to medical device noted upon otoscopy
- known hypersensitivity or allergy to materials of investigational device or comparator
- inability to produce reliable test results
- known psychological problems
- self reported symptoms of dizziness or vertigo
Data sourced from ClinicalTrials.gov (NCT05072470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.