Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)

NCT05106413 | Terminated

• 1 other identifier: SRF-377
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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).

  2 weeks

Secondary Outcomes (11)

• SI in noise (fix direction): BiCROS fitting vs. unaided

  2 week

• SI in diffuse noise: BiCROS fitting vs. monaural fitting

  2 weeks

• SI in diffuse noise: BiCROS fitting vs. unaided

  2 weeks

• SI in diffuse noise: BiCROS vs. CROS baseline fitting

  2 weeks

• SI in diffuse noise: CROS baseline fitting vs. unaided

  2 weeks

Study Arms (1)

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.

Other: BiCROS fitting; Other: Monaural fitting; Other: Unaided condition; Other: CROS baseline

Interventions

BiCROS fitting OTHER

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.

Speech Intelligibility with CROS device

Monaural fitting OTHER

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.

Speech Intelligibility with CROS device

Unaided condition OTHER

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

Speech Intelligibility with CROS device

CROS baseline OTHER

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.

Speech Intelligibility with CROS device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 31486692 BACKGROUND

• 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.

  PMID: 30541657 BACKGROUND

• 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.

  PMID: 30931220 BACKGROUND

• 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.

  PMID: 20457680 BACKGROUND

• 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.

  PMID: 18270178 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: October 26, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: April 15, 2022

Record last verified: 2021-11

Locations

CH (1)