Trials / Completed
CompletedNCT05612763
Self Fitting Hearing Aid Clinical Investigation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Starkey Laboratories, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids
Detailed description
The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Self fitting hearing device | comparison of outcomes when device is fit by clinician or self fit |
Timeline
- Start date
- 2022-08-18
- Primary completion
- 2022-10-03
- Completion
- 2022-10-10
- First posted
- 2022-11-10
- Last updated
- 2022-11-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05612763. Inclusion in this directory is not an endorsement.