N/A
N=20
Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT06700512 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Oldenburg Sentence Test — -6.6; -1.1; -3.5 dB — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hearing Aid Signia Pure C&G 7IX (Device); Own Hearing Aid (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- WSAUD A/S
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oldenburg Sentence Test |
-6.6; -1.1; -3.5 | <0.001 sig |
| SECONDARY Freiburger Monosyllabic Speech Test |
75.1; 31.5; 68.6 | — |
| SECONDARY Match-to-Target |
3.3; 1.6; 1.2; 1.6; 1.5 | — |
| SECONDARY Speech, Spatial and Qualities of Hearing Questionnaire (SSQ) |
6.2; 5.8; 6.9; 6.2; 7.9; 7.3 | — |
| SECONDARY International Outcome Inventory for Hearing Aids (IOI-HA) |
3.6; 3.8; 5.0; 4.9 | — |
| SECONDARY Satisfaction Questionnaire |
5.4; 5.5; 5.1; 5.1; 5.4; 5.2 | — |
Summary
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
Eligibility Criteria
Inclusion Criteria
- Hearing loss should fall within fitting range of study hearing aid
- They should be experienced hearing aid users
- Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
- Sensorineural HL, mild-to-moderate
- HL corresponding to the fitting range of the hearing aid
- Healthy (outer) ear
- Older than 18 years
- German is mother tongue
- Able to understand the instructions
- Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
- Informed consent
Exclusion Criteria
- Contraindication for hearing aid treatment
- Fluctuating or rapidly progressing hearing loss
- "Central" hearing problems
- Limited mobility
- Limited dexterity (in handling the hearing aid)
- Known psychological problems
Data sourced from ClinicalTrials.gov (NCT06700512). 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.