Status:
COMPLETED
Standard Post Market Clinical Follow-up (PMCF) Study WSA 2025
Lead Sponsor:
WSAUD A/S
Collaborating Sponsors:
Hoerzentrum Oldenburg
Conditions:
Hearing Loss, Sensorineural
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 mini...
Eligibility Criteria
Inclusion
- Sensorineural hearing loss, mild-to-moderately severe (Pure tone average of 500, 1000, 2000 and 4000 Hz \<65).
- Hearing loss should fall within fitting range of study hearing aid
- Subjects should be experienced hearing aid users who have had and used hearing aids daily for at least 1 year.
- Air-Bone-Gap should be less or equal to 20 dB.
- Asymmetry between left and right ear should not exceed 20dB for frequencies in the range of 250Hz to 4kHz
- Healthy (outer and middle) ear
- Older than 18 years
- German is mother tongue
- Able to understand the instructions
- Willing to participate in laboratory tests and to wear the study HAs at home for 2 weeks
- Informed consent
Exclusion
- Contraindication for HA treatment
- Fluctuating or rapidly progressing hearing loss
- "Central" hearing problems
- Limited mobility
- Limited dexterity (in handling the HA)
- Known psychological or cognitive problems
- Subjects must not show any injuries or a complete perforation of the ear drum. This must be clarified prior to the beginning of the study by means of otoscopy.
- Subjects should be in good overall medical condition (e.g., they shall not suffer from dementia) and should not use medical treatments that might affect study results.
Key Trial Info
Start Date :
February 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06986499
Start Date
February 25 2025
End Date
May 9 2025
Last Update
May 23 2025
Active Locations (1)
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1
Hörzentrum Oldenburg gGmbH
Oldenburg, Germany, Germany, 26129