N/A
Completed N=14
Validation of Novel BTE and SP Hearing Aid Models
Source: ClinicalTrials.gov NCT04882787 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Number of Participants With 'Total Impression' Sound Quality as 'Good' — 7; 6; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 'Total Impression' Sound Quality as 'Good' |
7; 6; 0; 1 | — |
| SECONDARY Number and Percentage of Participants Reporting No Reboots |
6; 6; 1; 1 | — |
| SECONDARY Number of Participants Reporting Perceived Differences With Both of the App Boost Controls |
7; 0 | — |
| SECONDARY Number of Participants Reporting Perceived Differences With Both of the App Slider Controls |
6; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04882787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.