Hearing Loss, SensorineuralNCT06986499
Standard Post Market Clinical Follow-up (PMCF) Study WSA 2025
A study testing Hearing Aid Widex SmartRIC MRRLD 440 and Own hearing aid in people with Hearing Loss, Sensorineural, run by WSAUD A/S at 1 site in Germany.
Trial summary
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Hearing Aid Widex SmartRIC MRRLD 440 and Own hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 25 Feb 2025to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WSA Standard PMCF Study 2025
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.
Read the 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).
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Hearing Aid Widex SmartRIC MRRLD 440, Own hearing aid
- Keywords
- Hearing aid, Freiburger, Matrix Test, SSQ, IOI-HA
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid Widex SmartRIC MRRLD 440Device
Receiver in Canal (RIC) hearing aid
Own hearing aidDevice
subjects' own hearing aids, any brand, any model
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Study Device with Own devices | Other | within subject design: compare Widex SmartRIC MRRLD 440 to subjects' own hearing aids Receives: Device: Hearing Aid Widex SmartRIC MRRLD 440; Device: Own hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Secondary outcomes (6)
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.
Measured: 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
Measured: Day 1 (Fitting procedure with real-ear measurements is done at first lab session)
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
A short form of the SSQ is used (SSQ 17, German version), to investigate speech perception, sound localisation, satisfaction and quality of hearing perceived in real-life. Responses are entered on a scale from 0 to 10, with 0 being the worst and 10 the best rating.
Measured: 2 weeks
International Outcome Inventory for Hearing Aids (IOI-HA)
Investigate outcomes and effectiveness of hearing aid usage in real-life. Responses are entered on a 5-point scale with captions going from worst to best.
Measured: 2 weeks
Satisfaction Questionnaire
Investigate satisfaction in real-life for different situations using proprietary questionnaire. Responses are entered on a 7 point likert scale with 1 signifying "Very dissatisfied" and 7 "very satisfied".
Measured: 2 weeks
Basic User need questionnaire
Investigate ability to carry out different hearing aid functions of the test hearing aids in daily life using proprietary questionnaire. Subject can respond "Yes", "No" or "N.A.".
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start25 Feb 2025
- Primary completion23 Apr 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- WSAUD A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoerzentrum Oldenburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986499
- Sponsor's protocol ID
- D00340960
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WSA Standard PMCF Study 2025
- ClinicalTrials.gov ID
- NCT06986499
- Acronym / sponsor ID
- D00340960
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Hearing aid, Freiburger, Matrix Test, SSQ, IOI-HA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- WSAUD A/SIndustry (pharma, biotech, devices)
- Collaborators
- Hoerzentrum Oldenburg
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of Study Device with Own devices | Other | Device: Hearing Aid Widex SmartRIC MRRLD 440, Device: Own hearing aidwithin subject design: compare Widex SmartRIC MRRLD 440 to subjects' own hearing aids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- Contraindication for HA treatment
- Fluctuating or rapidly progressing hearing loss
- "Central" hearing problems
- Limited mobility
- Limited dexterity (in handling the HA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aid Widex SmartRIC MRRLD 440Receiver in Canal (RIC) hearing aid | Device | Comparison of Study Device with Own devices |
| Own hearing aidsubjects' own hearing aids, any brand, any model | Device | Comparison of Study Device with Own devices |
Primary outcome
Oldenburg Sentence Test
Time frame: 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 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.
6 secondary outcomes
Freiburger Monosyllabic Speech Test
Time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Match-to-Target
Time frame: Day 1 (Fitting procedure with real-ear measurements is done at first lab session)
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
Time frame: 2 weeks
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: 2 weeks
Satisfaction Questionnaire
Time frame: 2 weeks
Basic User need questionnaire
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid Widex SmartRIC MRRLD 440 and Own hearing aid in people with Hearing Loss, Sensorineural, run by WSAUD A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oldenburg Sentence Test (time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.