N/A
N=10
Benefit of Assistive Listening Device for Lateralization
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT05072457 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Lateralization Hearing Ability — 71; 54 percent correct responses — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Roger On microphone (Device); Roger Select microphone (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lateralization Hearing Ability |
71; 54 | <.05 sig |
| PRIMARY Spatial Hearing Ability |
48; 42 | >.05 |
Summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
Eligibility Criteria
Inclusion Criteria
- Experienced hearing aid users, age 18 or older
- Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
- Good understanding of the English language
- Health outer ear as confirmed by otoscopy
- Informed consent as documented by signature
Exclusion Criteria
- Contraindications to the medical device noted upon otoscopy
- Known hypersensitivity or allergies to materials of the investigations device or comparator
- Inability to produce reliable test results
- Known psychological problems
- Self reported symptoms of vertigo or dizziness
Data sourced from ClinicalTrials.gov (NCT05072457). 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.