N/A
N=22
Remote Microphone Candidacy Study
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT03897634 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Change in Abbreviated Profile of Hearing Aid Benefit (APHAB) — 7.64; 12.5; 4.8; 6.3 % of Problems (Change from baseline)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Microphone (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Abbreviated Profile of Hearing Aid Benefit (APHAB) |
7.64; 12.5; 4.8; 6.3; -2.6 | — |
| SECONDARY Change in Speech, Spatial, and Qualities of Hearing (SSQ) |
1.7; 0.6; 1.1 | — |
| SECONDARY % of Words Repeated Correctly in a Sentence Recognition Task With Variable Levels of Background Noise |
60.0; 82.7 | — |
Summary
Despite improvements in digital hearing aid technology, many hearing aid users continue to report difficulty understanding speech in challenging listening environments. Remote microphones have been shown to provide benefit in the most common of these challenging listening environments: distant speakers, background noise, and reverberation. Despite demonstrated benefit, there is a low rate of remote microphone use among adult hearing aid users. One reason for low uptake may be an uncertainty among hearing healthcare providers and potential users regarding expected clinically relevant benefit. This clinical trial will attempt the following:
1. To describe the range of remote microphone benefit among adults with mild-to-moderate sensorineural hearing loss
2. To determine specific individual factors beyond the audiogram that are associated with greater benefit from remote microphones
Eligibility Criteria
Inclusion Criteria
- Adults age 18-85 years
- Speak English as their primary language
- Normal or corrected to normal vision
- Sensorineural hearing loss with pure-tone thresholds 20-85 dB HL at octave frequencies between 500 and 3000 Hz
- Current hearing aid wearer with at least 3 months of experience
Exclusion Criteria
- Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator places the participant at unacceptable risk if he or she were to participate in the study
- Participants who do not pass a cognitive screening test (e.g., MoCA)
- Significant history of otologic or neurologic disorders
- Conductive hearing loss pathology or fluctuating hearing loss
Data sourced from ClinicalTrials.gov (NCT03897634). 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.