Hearing LossNCT03755453
Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34
A study testing Hearing aid: Phonak Audéo B90-Direct in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aid: Phonak Audéo B90-Direct
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Oct 2018to 28 Feb 2019
- 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
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Informed Consent as documented by signature
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend appointments
- Limited ability to describe listening impressions or to use hearing aids/ accessories
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application
A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.
- Conditions
- Hearing Loss
- Being tested
- Hearing aid: Phonak Audéo B90-Direct
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aid: Phonak Audéo B90-DirectDevice
Hearing aids will be fitted to the participants individual hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| Audéo B-Direct fitted with fitting method A | Active comparator | Traditional standard fitting method which do not include adjustments from the participants. Receives: Device: Hearing aid: Phonak Audéo B90-Direct |
| Audéo B-Direct fitted with fitting method B | Experimental | Alternative fitting method which includes additional adjustments from the participants. Receives: Device: Hearing aid: Phonak Audéo B90-Direct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of fitting method A versus B in regard to sound quality
The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.
Measured: 2 months
Secondary outcomes (1)
Comparison of fitting method A versus B in regard to speech intelligibility in noise
The speech intelligibility in noise with hearing aid fitting method A versus B will be measured with the aid of the Oldenburg sentence test in dB Speech Reception Treshold (SRT).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start11 Oct 2018
- Primary completion31 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755453
- Sponsor's protocol ID
- Sonova2018_34
- Status last verified
- May 2019
- First submitted
- 28 Sep 2018
- Last updated
- 9 May 2019
- 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 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application
- ClinicalTrials.gov ID
- NCT03755453
- Acronym / sponsor ID
- Sonova2018_34
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 28 Nov 2018 (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.
A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
| Arm | Type | Receives |
|---|---|---|
| Audéo B-Direct fitted with fitting method A | Active comparator | Device: Hearing aid: Phonak Audéo B90-DirectTraditional standard fitting method which do not include adjustments from the participants. |
| Audéo B-Direct fitted with fitting method B | Experimental | Device: Hearing aid: Phonak Audéo B90-DirectAlternative fitting method which includes additional adjustments from the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: Phonak Audéo B90-DirectHearing aids will be fitted to the participants individual hearing loss. | Device | Audéo B-Direct fitted with fitting method A, Audéo B-Direct fitted with fitting method B |
Primary outcome
Comparison of fitting method A versus B in regard to sound quality
Time frame: 2 months
The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.
1 secondary outcome
Comparison of fitting method A versus B in regard to speech intelligibility in noise
Time frame: 2 months
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 9 May 2019.
- Individual participant dataSharing planned: No
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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: Phonak Audéo B90-Direct in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 May 2019. 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 Switzerland. 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?
Comparison of fitting method A versus B in regard to sound quality (time frame: 2 months). 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 9 May 2019.