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

Not Applicable

Completed

Conditions: Hearing Loss, Sensorineural

Registration Number: NCT06700512

Lead Sponsor: WSAUD A/S

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 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Hearing loss should fall within fitting range of study hearing aid
They should be experienced hearing aid users
Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
Sensorineural HL, mild-to-moderate
HL corresponding to the fitting range of the hearing aid
Healthy (outer) ear
Older than 18 years
German is mother tongue
Able to understand the instructions
Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
Informed consent

Exclusion Criteria

Contraindication for hearing aid treatment
Fluctuating or rapidly progressing hearing loss
"Central" hearing problems
Limited mobility
Limited dexterity (in handling the hearing aid)
Known psychological problems

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oldenburg Sentence Test	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 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.

Secondary Outcome Measures

Name	Time	Method
Freiburger Monosyllabic Speech Test	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.
Match-to-Target	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.
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)	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.
International Outcome Inventory for Hearing Aids (IOI-HA)	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").
Satisfaction Questionnaire	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.