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Evaluation of BiCROS Fitting Benefits

Sponsor
Sonova AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05379231
Collaborator
University of Western Ontario, Canada (Other)
23
Enrollment
1
Location
1
Arm
6.7
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

23 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.

Condition or Disease Intervention/Treatment Phase
  • Other: BiCROS fitting
  • Other: Monaural hearing aid fitting
  • Other: Unaided condition
 N/A

Detailed Description

Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.

One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so-called CROS transmitter together with a hearing aid.

The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluate the Benefit of a BiCROS Hearing Aid Fitting
Actual Study Start Date :
Jul 11, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Speech Intelligibility with CROS device

The focus of this study is on Speech Intelligibility (SI), evaluated by the US Matrix Test, which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant.

Other: BiCROS fitting
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear.

Other: Monaural hearing aid fitting
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. Monaural hearing aid fitting acts as control intervention.

Other: Unaided condition
No treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid. Unaided condition acts as control intervention.

Outcome Measures

Primary Outcome Measures

  1. Speech intelligibility in Noise measured with US Matrix Test (noise from a defined loudspeaker) [7 months]

    Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker and noise from the better ear's side

Secondary Outcome Measures

  1. Speech intelligibility in Noise measured with US Matrix Test (diffuse noise) [7 months]

    Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker in surrounding noise

  2. Reports of Subjective quality of hearing as assessed by the SSQ [7 months]

    Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale (Gatehouse, 2004)

  3. Reports of Subjective quality of hearing as assessed by the Bern Benefit Questionnaires [7 months]

    Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011)

  4. Sound quality ratings for Total Impression and Clarity using Gabriellson et al (1990) Ratings Scales [7 months]

    Ratings of speech in quiet and in noise presented via loudspeakers

  5. Subjective preference of hearing aid condition [7 months]

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

  6. Listening effort in noise using 7 point scale (Johnson et al, 2015) [7 months]

    Measuring listening effort for speech in multi-talker babble presented via loudspeaker

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Centre for Audiology London Ontario Canada N6G 1H1

Sponsors and Collaborators

  • Sonova AG
  • University of Western Ontario, Canada

Investigators

  • Principal Investigator: Susan Scollie, University of Western Ontario, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sonova AG
ClinicalTrials.gov Identifier:
NCT05379231
Other Study ID Numbers:
  • 461
First Posted:
May 18, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Deafness
Hearing Loss, Unilateral

Study Results

No Results Posted as of Jul 19, 2022