NCT07667140CompletedNot Applicable
WSA Standard PMCF Study 2026
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- WSAUD A/S
- Enrollment
- 24
- Locations
- 1
Study Overview
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 minimum of 18 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 1 appointment of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and tests of basic hearing-aid related task.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Investigators
Study Sites (1)
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