Clinical trial NCT04882787: Validation of Novel BTE and SP Hearing Aid Models
Official title: Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Sonova Canada Inc.
First posted: 2021-05-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 2 groups based on hearing aid gain needs; one similar intervention
Primary purpose: TREATMENT

Brief summary: Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.

Detailed description: During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.

Eligibility criteria: Inclusion Criteria:

* hearing aid candidacy (N2-N7 hearing loss)
* healthy outer and middle ears
* ability to complete questionnaires
* willingness to use smartphone
* informed consent documented by a signature
* willingness to wear a binaural BTE fitting
* willingness to use app and accessories
* willingness to adhere to COVID protocols

Exclusion Criteria:

* contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold
* limited mobility/not able to attend appointments
* limited ability to describe listening impressions/experiences
* inability to produce a reliable hearing test result
* limited dexterity - to point that participant cannot manage hearing aid insertion/removal
* known psychological disorders

Primary outcomes:
measure: Number of Participants With 'Total Impression' Sound Quality as 'Good'
timeFrame: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Secondary outcomes:
measure: Number and Percentage of Participants Reporting No Reboots
timeFrame: at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
measure: Number of Participants Reporting Perceived Differences With Both of the App Boost Controls
timeFrame: initial appointment (day of fitting of hearing aids)
measure: Number of Participants Reporting Perceived Differences With Both of the App Slider Controls
timeFrame: initial appointment (day of fitting of hearing aids)
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Unitron Hearing
state: Ontario
Study officials:
affiliation: Sonova AG
name: Jinyu Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166.
citation: Valente M, Van Vliet D. The Independent Hearing Aid Fitting Forum (IHAFF) Protocol. Trends Amplif. 1997 Mar;2(1):6-35. doi: 10.1177/108471389700200102. No abstract available.
citation: Likert, Rensis. A technique for the measurement of attitudes. Archives of Psychology. 1932; 140: 1-55.