N/A
N=27
Hearing Aid Signal Processing Comparative Study
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT04839289 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B — 7.16; 7.12 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Receiver-in-canal hearing instrument; Manufacturer A (Device); Receiver-in-canal hearing instrument; Manufacturer B (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B |
7.16; 7.12 | — |
| PRIMARY Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B |
7.61; 6.70 | — |
| PRIMARY Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B |
7.28; 7.52 | >0.05 |
| PRIMARY Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. |
3.94; 3.80 | — |
| PRIMARY Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. |
4.24; 3.76 | — |
| PRIMARY Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. |
4.12; 3.99 | <.01666667 sig |
Summary
Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe sensorineural hearing loss
- Current hearing aid user
Exclusion Criteria
- Lack of willingness to wear study devices for approximately one month
- Inability to travel to study appointments or to complete questionnaires.
Data sourced from ClinicalTrials.gov (NCT04839289). 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.