Skip to main content
OpenTrials
Completed

NCT Number: NCT06986499

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hörzentrum Oldenburg gGmbH

Oldenburg, Germany, 26129

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hearing Aid Widex SmartRIC MRRLD 440

Device

Receiver in Canal (RIC) hearing aid

Own hearing aid

Device

subjects' own hearing aids, any brand, any model

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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, satisfaction and quality of hearing perceived in real-life. Responses are entered on a scale from 0 to 10, with 0 being the worst and 10 the best rating.

  4. 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 entered on a 5-point scale with captions going from worst to best.

  5. Satisfaction Questionnaire

    Time frame: 2 weeks

    Investigate satisfaction in real-life for different situations using proprietary questionnaire. Responses are entered on a 7 point likert scale with 1 signifying "Very dissatisfied" and 7 "very satisfied".

  6. Basic User need questionnaire

    Time frame: 2 weeks

    Investigate ability to carry out different hearing aid functions of the test hearing aids in daily life using proprietary questionnaire. Subject can respond "Yes", "No" or "N.A.".

Sponsors and collaborators

Lead sponsor

WSAUD A/S

Industry

Collaborators

  • Hoerzentrum Oldenburg

Registry information

Official study title

WSA Standard PMCF Study 2025

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.