NCT05379231

Evaluation of BiCROS Fitting Benefits

Completed NA Results posted Last updated 11 June 2025

What this trial tests

NA trial testing Hearing aid fitting in Unilateral Deafness in 22 participants. Completed in 21 March 2023.

Timeline

11 July 2022

Primary endpoint
21 March 2023

21 March 2023

Quick facts

Lead sponsor	Sonova AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	22
Start date	11 July 2022
Primary completion	21 March 2023
Estimated completion	21 March 2023
Sites	2 locations across Canada

Drugs / interventions tested

• Hearing aid fitting

Conditions studied

• Unilateral Deafness — all drugs for Unilateral Deafness →

Sponsor

Sonova AG — full company profile →

Who can join

Adults 18 to 99, any sex, with Unilateral Deafness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker) Primary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker and noise from the better ear's side with the US matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A)). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 65 dB (A).

Group	Value	95% CI
BiCROS With Beamformer	-8.8	± 3.4
BiCROS Omni	-3.7	± 2.9
Monaural With Beamformer	-9.2	± 2.7
Monaural Omni	-2.8	± 2.5
Unaided	-0.1	± 6.8

Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise) Secondary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker in surrounding noise with the US Matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented from a circle of 8 surrounding speakers from 45° to 315° at a level of 65 dB (A) with the participant seated in the centre of the circle.

Group	Value	95% CI
BiCROS With Beamformer	-14.2	± 3.3
BiCROS Omni	-8	± 4.2
Monaural With Beamformer	-13.9	± 3.6
Monaural Omni	-9.3	± 3
Unaided	-3.4	± 9.4

Reports of Subjective Quality of Hearing as Assessed by the SSQ Secondary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale-Benefit (Gatehouse, 2004). The scale ranges from -5 to 5, where negative values indicate that the condition under test is worse than the comparator, 0 indicates no change, and positive values indicate a benefit of the condition under test compared to the comparator.

Speech

Group	Value	95% CI
BiCROS	2.48	± 0.59

Spatial

Group	Value	95% CI
BiCROS	1.16	± 0.47

Qualities

Group	Value	95% CI
BiCROS	2.55	± 0.35

Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires Secondary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011). The scale ranges from -5 to 5, where negative values indicate that the condition under test is better wihtout the hearing aid, 0 indicates no change, and positive values indicate a benefit with the hearing aid.

Group	Value	95% CI
BiCROS	2.83	± 0.76

Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales Secondary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Ratings of speech in noise presented via loudspeakers using Gabriellson et al (1990) Ratings Scales. Scales include Clarity and Total Impression, and range from 1 to 10. The higher the rating, the better the Clarity and Total Impression.

Clarity

Group	Value	95% CI
BiCROS With Beamformer	6.8	± 2.4
BiCROS Omni	5.2	± 2.8
Monaural With Beamformer	6.5	± 2.3
Monaural Omni	4.8	± 2.8
Unaided	3.7	± 3

Total Impression

Group	Value	95% CI
BiCROS With Beamformer	6.1	± 2.7
BiCROS Omni	4.7	± 2.8
Monaural With Beamformer	6	± 2.3
Monaural Omni	4.3	± 2.5
Unaided	3.7	± 2.6

Subjective Preference of Hearing Aid Condition Secondary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers

Group	Value	95% CI
BiCROS w/ Beamformer vs. Monaural w/ Beamformer	7
BiCROS Omni vs. Monaural Omni	11
BiCROS Omni vs. w/ Beamformer	2
Monaural Omni vs. w/ Beamformer	4
BiCROS w/ Beamformer vs. Monaural w/ Beamformer	6
BiCROS Omni vs. Monaural Omni	3
BiCROS Omni vs. w/ Beamformer	0
Monaural Omni vs. w/ Beamformer	0
BiCROS w/ Beamformer vs. Monaural w/ Beamformer	5
BiCROS Omni vs. Monaural Omni	4
BiCROS Omni vs. w/ Beamformer	0
Monaural Omni vs. w/ Beamformer	0
BiCROS w/ Beamformer vs. Monaural w/ Beamformer	0
BiCROS Omni vs. Monaural Omni	0
BiCROS Omni vs. w/ Beamformer	16
Monaural Omni vs. w/ Beamformer	14

Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018) Secondary · At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

Measuring listening effort for speech in multi-talker babble presented via loudspeaker. The scale ranges from 1 to 7, and a higher rating indicates less listening effort.

Group	Value	95% CI
BiCROS With Beamformer	3.75	± 1.8
BiCROS Omni	4.9	± 1.9
Monaural With Beamformer	3.9	± 1.6
Monaural Omni	5	± 1.5
Unaided	5.7	± 1.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first appointment the participant was enrolled and assessed, until the last appointment that concluded the home trial and study participation. The whole duration was about 5-6 weeks per participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Complete Sample

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (2 terms — click to expand)

Reaction	System	Complete Sample
Ear infection	Ear and labyrinth disorders	—
Early withdrawal (unrelated)	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT05379231 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.