N/A
N=20
Evaluation of BiCROS Fitting Benefits
Unilateral Deafness
Bottom Line
View on ClinicalTrials.gov: NCT05379231 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker) — -8.8; -3.7; -9.2; -2.8 dBSRT
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hearing aid fitting (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker) |
-8.8; -3.7; -9.2; -2.8; -0.1 | — |
| SECONDARY Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise) |
-14.2; -8; -13.9; -9.3; -3.4 | — |
| SECONDARY Reports of Subjective Quality of Hearing as Assessed by the SSQ |
2.48; 1.16; 2.55 | — |
| SECONDARY Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires |
2.83 | — |
| SECONDARY Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales |
6.8; 5.2; 6.5; 4.8; 3.7; 6.1 | — |
| SECONDARY Subjective Preference of Hearing Aid Condition |
7; 11; 2; 4; 6; 3 | — |
| SECONDARY Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018) |
3.75; 4.9; 3.9; 5; 5.7 | — |
Summary
22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.
Eligibility Criteria
Inclusion Criteria
- unaidable hearing loss in worse ear (>N6)
- aidable hearing loss (N3 to N5) on the other ear
- fluent English speaker
Exclusion Criteria
- aidable hearing loss in both ears
Data sourced from ClinicalTrials.gov (NCT05379231). 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.