Clinical trial NCT06986499: Standard Post Market Clinical Follow-up (PMCF) Study WSA 2025
Official title: WSA Standard PMCF Study 2025
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: Hearing aid
Freiburger
Matrix Test
SSQ
IOI-HA
Lead sponsor: WSAUD A/S
Sponsor class: INDUSTRY
Collaborators: name: Hoerzentrum Oldenburg
First posted: 2025-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Oldenburg Sentence Test
timeFrame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Secondary outcomes:
measure: Freiburger Monosyllabic Speech Test
timeFrame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
measure: Match-to-Target
timeFrame: Day 1 (Fitting procedure with real-ear measurements is done at first lab session)
measure: Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
timeFrame: 2 weeks
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: 2 weeks
measure: Satisfaction Questionnaire
timeFrame: 2 weeks
measure: Basic User need questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hörzentrum Oldenburg gGmbH
Study officials:
References: