Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-07-11
2023-03-21
Brief Summary
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Detailed Description
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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.
Hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the National Centre for Audiology in London, Ontario. Those visits are available at the Sonova Innovation Centre Toronto in Mississauga, Ontario, upon request. Outcome measurements are only conducted at the National Centre for Audiology in London, Ontario.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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BiCROS fitting with beamformer
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.
Hearing aid fitting
A participant will wear a hearing aid with and without a CROS device on the unaidable ear.
BiCROS fitting omni
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.
Hearing aid fitting
A participant will wear a hearing aid with and without a CROS device on the unaidable ear.
Monaural hearing aid fitting with beamformer
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.
Hearing aid fitting
A participant will wear a hearing aid with and without a CROS device on the unaidable ear.
Monaural hearing aid fitting omni
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.
Hearing aid fitting
A participant will wear a hearing aid with and without a CROS device on the unaidable ear.
Unaided condition
No intervention, the participants are not fitted with a CROS device and/or hearing aid.
No interventions assigned to this group
Interventions
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Hearing aid fitting
A participant will wear a hearing aid with and without a CROS device on the unaidable ear.
Eligibility Criteria
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Inclusion Criteria
* aidable hearing loss (N3 to N5) on the other ear
* fluent English speaker
Exclusion Criteria
18 Years
99 Years
ALL
Yes
Sponsors
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Western University, Canada
OTHER
Sonova AG
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Scollie
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
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National Centre for Audiology
London, Ontario, Canada
Sonova Innovation Centre Toronto
Mississauga, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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461
Identifier Type: -
Identifier Source: org_study_id
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