An interventional study of In-the-Ear Hearing Aid and Own hearing aid in Hearing Loss, Sensorineural, sponsored by WSAUD A/S. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by WSAUD A/S · Not applicable, Interventional, and Other
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.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 24 is below the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →WSAUD A/S is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
within subject design: compare Signia Insio 7IX ITC and Signia Silk 7IX to subjects' own hearing aids
Device: In-the-Ear Hearing Aid · Device: Own hearing aid
Custom In-the-Ear hearing aid. Form Factor In the Canal (ITC)
subjects' own hearing aids, any brand, any model
Instant Fit Hearing Aid, Form Factor CIC
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).
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.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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WSAUD A/S