Standard Post Market Clinical Follow-up (PMCF) Study WSA 2026

June 18, 2026 updated by: WSAUD A/S

WSA Standard PMCF Study 2026

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 18 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 1 appointment of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and tests of basic hearing-aid related task.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Germany
      • Oldenburg, Germany, Germany, 26129
        • Hörzentrum Oldenburg gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Comparison of Study Devices with Own devices
within subject design: compare Signia Insio 7IX ITC and Signia Silk 7IX to subjects' own hearing aids
Device: Own hearing aid
subjects' own hearing aids, any brand, any model
Device: In-the-Ear Hearing Aid
Custom In-the-Ear hearing aid. Form Factor In the Canal (ITC)
Device: In-the-Ear Hearing Aid
Instant Fit Hearing Aid, Form Factor CIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oldenburg Sentence Test
Time Frame: 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.
Estimated Time Frame 2 weeks (Test conducted at second lab session).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freiburger Monosyllabic Speech Test
Time Frame: 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.
Estimated Time Frame 2 weeks (Test conducted at second lab session).
Match-to-Target
Time Frame: 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
Day 1 (Fitting procedure with real-ear measurements is done at first lab session)
Basic user need documentation
Time Frame: One session of approximately 2 hours.
Investigate ability to carry out different hearing-aid related tasks with the test hearing aids documenting if the subjects can carry out the task without support / with support of IFU / with support of Audiologist / Not at all.
One session of approximately 2 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WSAUD A/S

Collaborators

Hoerzentrum Oldenburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D00369449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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