18 and older, any sex, with Hearing Loss, Sensorineural. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Oldenburg Sentence TestPrimary· 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 8
Group
Value
95% CI
Results With Study Device
-6.6
± 4.5
Results Unaided
-1.1
± 7.5
Results With Own Devices
-3.5
± 5.1
Freiburger Monosyllabic Speech TestSecondary· 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.
Group
Value
95% CI
Results With Study Device
75.1
± 12.3
Results Unaided
31.5
± 20.1
Results With Own Devices
68.6
± 12.7
Match-to-TargetSecondary· 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.
Deviation from Target @ 250 Hz
Group
Value
95% CI
Match-to-Target Study Devices
3.3
± 4.0
Deviation from Target @ 500 Hz
Group
Value
95% CI
Match-to-Target Study Devices
1.6
± 1.7
Deviation from Target @ 1000 Hz
Group
Value
95% CI
Match-to-Target Study Devices
1.2
± 1.4
Deviation from Target @ 2000 Hz
Group
Value
95% CI
Match-to-Target Study Devices
1.6
± 1.9
Deviation from Target @ 4000 Hz
Group
Value
95% CI
Match-to-Target Study Devices
1.5
± 1.7
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)Secondary· 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.
Speech Perception
Group
Value
95% CI
With Study Device
6.2
± 2.3
With Own Devices
5.8
± 1.9
Sound Localization
Group
Value
95% CI
With Study Device
6.9
± 2.4
With Own Devices
6.2
± 1.6
Quality of Hearing
Group
Value
95% CI
With Study Device
7.9
± 1.3
With Own Devices
7.3
± 1.7
International Outcome Inventory for Hearing Aids (IOI-HA)Secondary· 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").
Mean effectiveness ratings
Group
Value
95% CI
With Study Device
3.6
± 1.0
With Own Devices
3.8
± 0.7
Wearing Time
Group
Value
95% CI
With Study Device
5.0
± 0.2
With Own Devices
4.9
± 0.3
Satisfaction QuestionnaireSecondary· 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.
Sound quality overall
Group
Value
95% CI
With Study Device
5.4
± 1.3
With Own Devices
5.5
± 1.2
Overall Satisfaction
Group
Value
95% CI
With Study Device
5.1
± 1.5
With Own Devices
5.1
± 1.5
Naturalness
Group
Value
95% CI
With Study Device
5.4
± 1.4
With Own Devices
5.2
± 1.5
Conversation with one person
Group
Value
95% CI
With Study Device
5.4
± 1.6
With Own Devices
5.6
± 1.4
Comfort with loud sounds
Group
Value
95% CI
With Study Device
5.0
± 1.3
With Own Devices
4.5
± 1.4
Sponsor's own description
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by WSAUD A/S
Last refreshed: 8 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06700512.