Back to resultsEvaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
Primary Purpose
Hearing Loss
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
BiCROS fitting
Monaural fitting
Unaided condition
CROS baseline
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- hearing impaired adults, with & w/o hearing aids (experiences)
- good written and spoken (Swiss) German language skills
- ability to fill in a questionnaire conscientiously
- informed consent as documented by signature
- asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
- availability of Smartphone
- availability of TV or Tablet
- ability to operate and handle the investigational device
- ability to describe listening impressions/experiences and the use of the hearing aid
- Ability to produce a reliable hearing test result
Exclusion Criteria:
- Contraindications to the medical device:
- aidable hearing loss on the intended CROS side
- acute tinnitus (in either one ear and occurrence less than three months)
- anatomical deformity of the CROS ear (e.g. absence of the auricle)
- Known hypersensitivity or allergy to materials of the investigational device
- any auricle deformities, that prevents secure placement of the (test) devices
- no willingness to test the investigational device system
- no willingness to test the investigational device system for at least 8h a day
- Hint for psychological problems from investigators point of view
- reported fluctuating hearing that could influence the test result
- reported symptoms of vertigo and dizziness by participants
Sites / Locations
- Sonova AG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Speech Intelligibility with CROS device
Arm Description
The focus of this study is on Speech Intelligibility (SI), evaluated by the Oldenburg Sentence test (OLSA), 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.
Outcomes
Primary Outcome Measures
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
The primary objective of this clinical investigation is to evaluate whether a BiCROS fitting (better ear fitted with a hearing device, unaidable ear supplied with a CROS device) improves speech intelligibility in noise compared to a monaural fitting (just the aidable ear is supplied by a hearing aid), for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA). 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 70 dB (A).
Secondary Outcome Measures
SI in noise (fix direction): BiCROS fitting vs. unaided
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in noise compared to an unaided condition, for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA).
Results of the speech test will be the SRT (dB SNR). 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 70 dB (A).
SI in diffuse noise: BiCROS fitting vs. monaural fitting
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to a monaural hearing aid fitting.
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 70 dB (A).
SI in diffuse noise: BiCROS fitting vs. unaided
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to an unaided condition.
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 70 dB (A).
SI in diffuse noise: BiCROS vs. CROS baseline fitting
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in diffuse noise compared with a CROS baseline fitting. CROS baseline means a fitting of an additional program with different hearing instrument microphone setup.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
SI in diffuse noise: CROS baseline fitting vs. unaided
A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with an unaided condition.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
SI in diffuse noise: CROS baseline fitting vs. monaural fitting
A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with a monaural fitting.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
SP in diffuse noise: monaural fitting vs. unaided
A secondary objective of this clinical investigation is to evaluate whether a monaural fitting improves speech intelligibility in diffuse noise compared with an unaided condition.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
Evaluation of Sound quality
A secondary objective of this study is to evaluate the participant's satisfaction of the sound quality of the experimental CROS device by a subjective rating during a three-week home trial period.
Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied
Evaluation of System stability
A secondary objective of this study is to evaluate the participant's satisfaction of the system stability of the experimental CROS device during a three-week home trial period.
The participant shall report, if there are artefacts audible: never/ 1-2 times a week/ 3-6 times a week/ daily
Evaluation of streaming
A secondary objective of this study is to evaluate the participant's satisfaction of the streaming sound quality of the experimental CROS device, by a subjective rating during a three-week home trial period.
Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied
Evaluation of listening effort
A secondary objective is to evaluate the subjective listening effort in noise reported by the participant whilst wearing the experimental CROS device.
Scale: not at all - slightly - somewhat - moderately - very - extremely
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05106413
Brief Title
Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
Official Title
Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
This clinical trial has been early terminated due to recruiting issues of the calculated sample size.
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will evaluate the clinical benefit of a transmitter for contralateral routing of signals. The benefit will be evaluated in noisy environments regarding speech intelligibility when the CROS system is adjusted to different microphone settings. Additionally, data regarding overall system stability, crash reboot rate, sound quality and connectivity will be obtained over a period of time to validate the CROS system in combination with smartphone and accessories. This study is a confirmatory study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speech Intelligibility with CROS device
Arm Type
Experimental
Arm Description
The focus of this study is on Speech Intelligibility (SI), evaluated by the Oldenburg Sentence test (OLSA), 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.
Intervention Type
Other
Intervention Name(s)
BiCROS fitting
Intervention Description
Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible hearing device on the other ear.
Intervention Type
Other
Intervention Name(s)
Monaural fitting
Intervention Description
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the poorer, unaidable ear.
Monaural hearing aid fitting acts as control intervention.
Intervention Type
Other
Intervention Name(s)
Unaided condition
Intervention Description
No treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid.
Unaided condition acts as control intervention.
Intervention Type
Other
Intervention Name(s)
CROS baseline
Intervention Description
Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible device on the other ear. The difference to the BiCROS condition is the setup of the microphones in the CROS device and the compatible hearing device.
This test condition is only tested for speech intelligibility in diffuse noise and acts as control intervention.
Primary Outcome Measure Information:
Title
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
Description
The primary objective of this clinical investigation is to evaluate whether a BiCROS fitting (better ear fitted with a hearing device, unaidable ear supplied with a CROS device) improves speech intelligibility in noise compared to a monaural fitting (just the aidable ear is supplied by a hearing aid), for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA). 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 70 dB (A).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
SI in noise (fix direction): BiCROS fitting vs. unaided
Description
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in noise compared to an unaided condition, for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA).
Results of the speech test will be the SRT (dB SNR). 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 70 dB (A).
Time Frame
2 week
Title
SI in diffuse noise: BiCROS fitting vs. monaural fitting
Description
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to a monaural hearing aid fitting.
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 70 dB (A).
Time Frame
2 weeks
Title
SI in diffuse noise: BiCROS fitting vs. unaided
Description
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to an unaided condition.
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 70 dB (A).
Time Frame
2 weeks
Title
SI in diffuse noise: BiCROS vs. CROS baseline fitting
Description
A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in diffuse noise compared with a CROS baseline fitting. CROS baseline means a fitting of an additional program with different hearing instrument microphone setup.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
Time Frame
2 weeks
Title
SI in diffuse noise: CROS baseline fitting vs. unaided
Description
A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with an unaided condition.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
Time Frame
2 weeks
Title
SI in diffuse noise: CROS baseline fitting vs. monaural fitting
Description
A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with a monaural fitting.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
Time Frame
2 weeks
Title
SP in diffuse noise: monaural fitting vs. unaided
Description
A secondary objective of this clinical investigation is to evaluate whether a monaural fitting improves speech intelligibility in diffuse noise compared with an unaided condition.
The SI will be tested with the OLSA in diffuse noise. 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 70 dB (A).
Time Frame
2 weeks
Title
Evaluation of Sound quality
Description
A secondary objective of this study is to evaluate the participant's satisfaction of the sound quality of the experimental CROS device by a subjective rating during a three-week home trial period.
Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied
Time Frame
3 weeks
Title
Evaluation of System stability
Description
A secondary objective of this study is to evaluate the participant's satisfaction of the system stability of the experimental CROS device during a three-week home trial period.
The participant shall report, if there are artefacts audible: never/ 1-2 times a week/ 3-6 times a week/ daily
Time Frame
3 weeks
Title
Evaluation of streaming
Description
A secondary objective of this study is to evaluate the participant's satisfaction of the streaming sound quality of the experimental CROS device, by a subjective rating during a three-week home trial period.
Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied
Time Frame
3 weeks
Title
Evaluation of listening effort
Description
A secondary objective is to evaluate the subjective listening effort in noise reported by the participant whilst wearing the experimental CROS device.
Scale: not at all - slightly - somewhat - moderately - very - extremely
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hearing impaired adults, with & w/o hearing aids (experiences)
good written and spoken (Swiss) German language skills
ability to fill in a questionnaire conscientiously
informed consent as documented by signature
asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
availability of Smartphone
availability of TV or Tablet
ability to operate and handle the investigational device
ability to describe listening impressions/experiences and the use of the hearing aid
Ability to produce a reliable hearing test result
Exclusion Criteria:
Contraindications to the medical device:
aidable hearing loss on the intended CROS side
acute tinnitus (in either one ear and occurrence less than three months)
anatomical deformity of the CROS ear (e.g. absence of the auricle)
Known hypersensitivity or allergy to materials of the investigational device
any auricle deformities, that prevents secure placement of the (test) devices
no willingness to test the investigational device system
no willingness to test the investigational device system for at least 8h a day
Hint for psychological problems from investigators point of view
reported fluctuating hearing that could influence the test result
reported symptoms of vertigo and dizziness by participants
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
31486692
Citation
Bagatto M, DesGeorges J, King A, Kitterick P, Laurnagaray D, Lewis D, Roush P, Sladen DP, Tharpe AM. Consensus practice parameter: audiological assessment and management of unilateral hearing loss in children. Int J Audiol. 2019 Dec;58(12):805-815. doi: 10.1080/14992027.2019.1654620. Epub 2019 Sep 5.
Results Reference
background
PubMed Identifier
30541657
Citation
Snapp HA, Hoffer ME, Spahr A, Rajguru S. Application of Wireless Contralateral Routing of Signal Technology in Unilateral Cochlear Implant Users with Bilateral Profound Hearing Loss. J Am Acad Audiol. 2019 Jul/Aug;30(7):579-589. doi: 10.3766/jaaa.17121. Epub 2018 Dec 13.
Results Reference
background
PubMed Identifier
30931220
Citation
Snapp H. Nonsurgical Management of Single-Sided Deafness: Contralateral Routing of Signal. J Neurol Surg B Skull Base. 2019 Apr;80(2):132-138. doi: 10.1055/s-0039-1677687. Epub 2019 Jan 17.
Results Reference
background
PubMed Identifier
20457680
Citation
Lieu JE, Tye-Murray N, Karzon RK, Piccirillo JF. Unilateral hearing loss is associated with worse speech-language scores in children. Pediatrics. 2010 Jun;125(6):e1348-55. doi: 10.1542/peds.2009-2448. Epub 2010 May 10.
Results Reference
background
PubMed Identifier
18270178
Citation
McKay S, Gravel JS, Tharpe AM. Amplification considerations for children with minimal or mild bilateral hearing loss and unilateral hearing loss. Trends Amplif. 2008 Mar;12(1):43-54. doi: 10.1177/1084713807313570.
Results Reference
background
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Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
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