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

NCT ID: NCT06986499

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2025-05-09

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).

Conditions

Hearing Loss, Sensorineural

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Comparison of Study Device with Own devices

within subject design: compare Widex SmartRIC MRRLD 440 to subjects' own hearing aids

Group Type: OTHER

Hearing Aid Widex SmartRIC MRRLD 440

Intervention Type: DEVICE

Receiver in Canal (RIC) hearing aid

Own hearing aid

Intervention Type: DEVICE

subjects' own hearing aids, any brand, any model

Interventions

Hearing Aid Widex SmartRIC MRRLD 440

Receiver in Canal (RIC) hearing aid

Intervention Type: DEVICE

Own hearing aid

subjects' own hearing aids, any brand, any model

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoerzentrum Oldenburg

UNKNOWN

Sponsor Role: collaborator

WSAUD A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hörzentrum Oldenburg gGmbH

Oldenburg, Germany, Germany

Countries

Germany

Other Identifiers

D00340960

Identifier Type: -

Identifier Source: org_study_id