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

WSAUD A/S24 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

In-the-Ear Hearing AidDEVICE

Custom In-the-Ear hearing aid. Form Factor In the Canal (ITC)

Own hearing aidDEVICE

subjects' own hearing aids, any brand, any model

In-the-Ear Hearing AidDEVICE

Instant Fit Hearing Aid, Form Factor CIC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hörzentrum Oldenburg gGmbH

Oldenburg, Germany, Germany

Outcomes

Primary Outcomes

Oldenburg Sentence Test

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.

Time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).

Secondary Outcomes

Freiburger Monosyllabic Speech Test

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.

Time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).

Match-to-Target

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

Time frame: Day 1 (Fitting procedure with real-ear measurements is done at first lab session)

Basic user need documentation

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.

Time frame: One session of approximately 2 hours.

Data from ClinicalTrials.gov

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