Clinical trial NCT05106413: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
timeFrame: 2 weeks
Secondary outcomes:
measure: SI in noise (fix direction): BiCROS fitting vs. unaided
timeFrame: 2 week
measure: SI in diffuse noise: BiCROS fitting vs. monaural fitting
timeFrame: 2 weeks
measure: SI in diffuse noise: BiCROS fitting vs. unaided
timeFrame: 2 weeks
measure: SI in diffuse noise: BiCROS vs. CROS baseline fitting
timeFrame: 2 weeks
measure: SI in diffuse noise: CROS baseline fitting vs. unaided
timeFrame: 2 weeks
measure: SI in diffuse noise: CROS baseline fitting vs. monaural fitting
timeFrame: 2 weeks
measure: SP in diffuse noise: monaural fitting vs. unaided
timeFrame: 2 weeks
measure: Evaluation of Sound quality
timeFrame: 3 weeks
measure: Evaluation of System stability
timeFrame: 3 weeks
measure: Evaluation of streaming
timeFrame: 3 weeks
measure: Evaluation of listening effort
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
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.
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.
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.
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.
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.