Standard Post Market Clinical Follow-up (PMCF) Study WSA 2025

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural

• Registration Number: NCT06986499
• Lead Sponsor: WSAUD A/S

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 16 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and undergo two 2-weeks home trials of the test hearing aid (with questionnaires).

Study Timeline

• Study Start: 2025-02-25
• Primary Completion: 2025-04-23
• Status Verified: 2025-05
• Study Completion: 2025-05-09
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oldenburg Sentence Test	Estimated Time Frame 2 weeks (Test conducted at second lab session).	The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold in quiet and in noise. Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired.

Secondary Outcome Measures

Name	Time	Method
Freiburger Monosyllabic Speech Test	Estimated Time Frame 2 weeks (Test conducted at second lab session).	To investigate speech intelligibility (SI) performance for speech at 65dB in a quiet listening situation, the Freiburger monosyllabic speech test is used which is still the gold standard for Hearing Care Professionals (HCPs) in Germany.
Match-to-Target	Day 1 (Fitting procedure with real-ear measurements is done at first lab session)	Investigate how close the study hearing aids fitted with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)	2 weeks	A short form of the SSQ is used (SSQ 17, German version), to investigate speech perception, sound localisation, satisfaction and quality of hearing perceived in real-life. Responses are entered on a scale from 0 to 10, with 0 being the worst and 10 the best rating.
International Outcome Inventory for Hearing Aids (IOI-HA)	2 weeks	Investigate outcomes and effectiveness of hearing aid usage in real-life. Responses are entered on a 5-point scale with captions going from worst to best.
Satisfaction Questionnaire	2 weeks	Investigate satisfaction in real-life for different situations using proprietary questionnaire. Responses are entered on a 7 point likert scale with 1 signifying "Very dissatisfied" and 7 "very satisfied".
Basic User need questionnaire	2 weeks	Investigate ability to carry out different hearing aid functions of the test hearing aids in daily life using proprietary questionnaire. Subject can respond "Yes", "No" or "N.A.".

Trial Locations

Locations (1)

Hörzentrum Oldenburg gGmbH; 🇩🇪 Oldenburg, Germany