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

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural

• Registration Number: NCT06700512
• 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 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).

Study Timeline

• Study Start: 2024-06-14
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-26
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

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

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

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	1 day (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
International Outcome Inventory for Hearing Aids (IOI-HA)	2 weeks	Investigate outcomes and effectiveness of hearing aid usage in real-life
Satisfaction Questionnaire	2 weeks	Investigate satisfaction in real-life for different situations

Trial Locations

Locations (1)

Hörzentrum Oldenburg gGmbH; 🇩🇪 Oldenburg, Germany