Validation of Novel BTE and SP Hearing Aid Models
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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