NCT06986499

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

WSA Standard PMCF Study 2025

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: WSAUD A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Hearing Aid Widex SmartRIC MRRLD 440	Receiver in Canal (RIC) hearing aid
DEVICE	Own hearing aid	subjects' own hearing aids, any brand, any model

Timeline

• Start date: 2025-02-25
• Primary completion: 2025-04-23
• Completion: 2025-05-09
• First posted: 2025-05-23
• Last updated: 2025-05-23

Locations

1 site across 1 country: Germany