N/A
Completed N=33
A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System
Source: ClinicalTrials.gov NCT04146272 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Change in Live Feedback Test Scores From Day 10 to Day 20 — 1.7; 1.7; 0.1; 0.1 units on a scale
Summary
The Purpose of the study is to show that the performance of the new feedback cancellation system is better than the feedback system used in the currently marketed hearing aids. Speech understanding should not be negatively affected by the new system, ad there should be no consequential artifacts or unwanted noises caused by the new system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Live Feedback Test Scores From Day 10 to Day 20 |
1.7; 1.7; 0.1; 0.1 | — |
| SECONDARY Word Recognition - Aided |
0.92; 0.92; 0.77; 0.77; 0.91; 0.91 | — |
| SECONDARY Sound Quality Rating |
1.6; 1.6; 1.5; 1.5 | — |
| SECONDARY Word Recognition - Unaided |
0.79; 0.79; 0.40; 0.40 | — |
Eligibility Criteria
Inclusion Criteria
- All classifications of hearing loss (sensorineural, conductive, mixed)
- Conductive and mixed hearing loss must be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to profound
- German speaking
- Ability and willingness to sign the consent form
Exclusion Criteria
- Contraindications for amplification
- Active ear disease
- New hearing aid users
- Inability to follow the procedures
- Reduced mobility that makes then unable to attend study Appointments
- Uncooperative so that it's not possible to get a valid audiogram
- A strongly reduced dexterity
- Central hearing disorder
- Sponsor employees
- Family members of Sponsor employees
Data sourced from ClinicalTrials.gov (NCT04146272). 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.