Hearing LossNCT05106413
Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
A study testing BiCROS fitting, Monaural fitting and Unaided condition in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- BiCROS fitting, Monaural fitting and Unaided condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Oct 2021to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- BiCROS fitting, Monaural fitting, Unaided condition, CROS baseline
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiCROS fittingOther
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.
Monaural fittingOther
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.
Unaided conditionOther
No treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid.
Unaided condition acts as control intervention.
CROS baselineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Speech Intelligibility with CROS device | Experimental | 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. Receives: Other: BiCROS fitting; Other: Monaural fitting; Other: Unaided condition; Other: CROS baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (11)
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).
Measured: 2 week
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).
Measured: 2 weeks
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).
Measured: 2 weeks
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).
Measured: 2 weeks
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).
Measured: 2 weeks
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).
Measured: 2 weeks
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).
Measured: 2 weeks
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
Measured: 3 weeks
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
Measured: 3 weeks
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
Measured: 3 weeks
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start26 Oct 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Why it stopped: This clinical trial has been early terminated due to recruiting issues of the calculated sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106413
- Sponsor's protocol ID
- SRF-377
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31486692Snapp 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.
PubMed 30541657Snapp 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.
PubMed 30931220Lieu 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.
PubMed 20457680McKay 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.
PubMed 18270178
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)
- ClinicalTrials.gov ID
- NCT05106413
- Acronym / sponsor ID
- SRF-377
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This clinical trial has been early terminated due to recruiting issues of the calculated sample size.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speech Intelligibility with CROS device | Experimental | Other: BiCROS fitting, Other: Monaural fitting, Other: Unaided condition, Other: CROS baselineThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiCROS fittingEach participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible hearing device on the other ear. | Other | Speech Intelligibility with CROS device |
| Monaural fittingEach 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. | Other | Speech Intelligibility with CROS device |
| Unaided conditionNo treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid. Unaided condition acts as control intervention. | Other | Speech Intelligibility with CROS device |
| CROS baselineEach 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. | Other | Speech Intelligibility with CROS device |
Primary outcome
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
Time frame: 2 weeks
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).
11 secondary outcomes
SI in noise (fix direction): BiCROS fitting vs. unaided
Time frame: 2 week
SI in diffuse noise: BiCROS fitting vs. monaural fitting
Time frame: 2 weeks
SI in diffuse noise: BiCROS fitting vs. unaided
Time frame: 2 weeks
SI in diffuse noise: BiCROS vs. CROS baseline fitting
Time frame: 2 weeks
SI in diffuse noise: CROS baseline fitting vs. unaided
Time frame: 2 weeks
SI in diffuse noise: CROS baseline fitting vs. monaural fitting
Time frame: 2 weeks
SP in diffuse noise: monaural fitting vs. unaided
Time frame: 2 weeks
Evaluation of Sound quality
Time frame: 3 weeks
Evaluation of System stability
Time frame: 3 weeks
Evaluation of streaming
Time frame: 3 weeks
Evaluation of listening effort
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: This clinical trial has been early terminated due to recruiting issues of the calculated sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 31486692Bagatto 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.
- Background: PubMed 30541657Snapp 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.
- Background: PubMed 30931220Snapp 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.
- Background: PubMed 20457680Lieu 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.
- Background: PubMed 18270178McKay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiCROS fitting, Monaural fitting and Unaided condition in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This clinical trial has been early terminated due to recruiting issues of the calculated sample size.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05106413, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.