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

WS Audiology (WSAUD)

Status

Completed

Conditions

Hearing Loss, Sensorineural

Treatments

Device: Own hearing aid

Device: Hearing Aid Widex SmartRIC MRRLD 440

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06986499

D00340960

Details and patient eligibility

About

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

Full 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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.