CompletedNot Applicable

Standard Post Market Clinical Follow-up (PMCF) Study WSA 2026

Germany24 participantsStarted 2026-03-25

Plain-language summary

The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oldenburg Sentence Test

Timeframe: Estimated Time Frame 2 weeks (Test conducted at second lab session).

Trial details

NCT IDNCT07667140

SponsorWSAUD A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Hearing Loss, Sensorineural trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.