Trials / Completed
CompletedNCT06700512
Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO
Standard PMCF Study WSA @ HZO
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- WSAUD A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
Detailed description
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hearing Aid Signia Pure C&G 7IX | Receiver in Canal (RIC) hearing aid, M Receiver |
| DEVICE | Own Hearing Aid | subjects' own hearing aids, any brand, any model |
Timeline
- Start date
- 2024-06-14
- Primary completion
- 2024-08-13
- Completion
- 2024-08-26
- First posted
- 2024-11-22
- Last updated
- 2025-08-08
- Results posted
- 2025-08-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06700512. Inclusion in this directory is not an endorsement.