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

July 22, 2025 updated by: WSAUD A/S

Standard PMCF Study WSA @ HZO

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 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 Type

Interventional

Enrollment (Actual)

20

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
      • Oldenburg, 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:

  • 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 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
Experimental: Evaluation of Study Device followed by Own devices
within subject design: Subjects wear the study devices for 2 weeks followed by wearing their own hearing aids for 2 weeks. Study devices are fitted as per standard-of-care.
Device: Hearing Aid Signia Pure C&G 7IX
Receiver in Canal (RIC) hearing aid, M Receiver
Device: Own Hearing Aid
subjects' own hearing aids, any brand, any model

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 (SRT in dB). 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. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
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. Results are reported in Percent correct data. Minimum is 0%, maximum is 100% with higher values meaning better speech understanding.
Estimated Time Frame 2 weeks (Test conducted at second lab session).
Match-to-Target
Time Frame: 1 day (Fitting procedure with real-ear measurements is done at first lab session)
Investigate how close the study hearing aids fitted and fine-tuned with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements. Absolute deviations were calculated at specific frequencies ranging from 250 Hz to 4 kHz. Unit of measure is dB SPL. Minimum Value is 0 (i.e. measured value and target value identical), no maximum value. Higher values mean greater deviation from target.
1 day (Fitting procedure with real-ear measurements is done at first lab session)
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
Time Frame: 2 weeks
A short form of the SSQ is used (SSQ 17, German version), to investigate speech perception, sound localisation, quality of hearing perceived in real-life. Questions are answered on a scale from 0 to 10, higher scores mean better outcomes. The responses to the individual questions are grouped for the subsections (speech, spatial, quality) by calculating the means.
2 weeks
International Outcome Inventory for Hearing Aids (IOI-HA)
Time Frame: 2 weeks
Investigate outcomes and effectiveness of hearing aid usage in real-life. Responses are given on a scale from 1 - 5. Here, the mean of questions 2 -7 is reported. Higher values represent better outcomes. Question 1 was on wearing time, which is not considered a rating of effectiveness and was therefore excluded from the mean and will be reported separately. Fpr wearing times higher values represent longer wearing time (maximum 5 equals "more than 8 hours a day").
2 weeks
Satisfaction Questionnaire
Time Frame: 2 weeks
Investigate satisfaction in real-life for different aspects such as sound quality, naturalness of sound, conversation with one person and overall satisfaction. Each aspect was assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied) The overall satisfaction and sound quality overall were individual questions and are not the combination of different situations/aspects. These questions were also assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied). Higher values represent better outcomes.
2 weeks

Collaborators and Investigators

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

Sponsor

WSAUD A/S

Investigators

  • Principal Investigator: Matthias Vormann, PhD, Hörzentrum Oldenburg gGmbH

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)

June 14, 2024

Primary Completion (Actual)

August 13, 2024

Study Completion (Actual)

August 26, 2024

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D00325215

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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