Hearing LossNCT04187781
Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
A study testing external microphone in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. 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?
- external microphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2019to 17 Jan 2020
- 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
- experienced hearing aid user
- severe hearing loss
- willingness and interest in testing an external microphone healthy outer ear
- willingness to wear behind the ear hearing aids
- Informed Consent as documented by signature
Who cannot join
- the audiogram is not in the fitting range of the intended hearing aid
- limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- participant is not able to describe experiences and hearing impressions
Trial locations and contacts
1 site in 1 country.
About this study
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Read the detailed description
This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.
The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).
The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.
This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
- Conditions
- Hearing Loss
- Being tested
- external microphone
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external microphoneDevice
External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.
| Study group | Role | What they receive |
|---|---|---|
| external microphone old | Other | Not described Receives: Device: external microphone |
| external microphone new | Other | Not described Receives: Device: external microphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of the subjective comfort for the old and the new setting
Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)
Measured: 6 weeks
Secondary outcomes (3)
Evaluation of the speech intelligibility in noise
Another Outcome measure of this study is the Evaluation of speech understanding in noise of the device with the old setting and the new setting. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in %.
Measured: 2 weeks
Subjective Sound Quality rating
The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the signal with the old setting, compared to the new setting of the external microphone.
Measured: 6 weeks
Subjective rating of natural sounds
The subject should rate in the hometrial how natural environmental sounds are with the hearing aids.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start11 Nov 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 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
- NCT04187781
- Sponsor's protocol ID
- Sonova2019_34
- Status last verified
- Feb 2020
- First submitted
- 3 Dec 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
- ClinicalTrials.gov ID
- NCT04187781
- Acronym / sponsor ID
- Sonova2019_34
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 5 Dec 2019 (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.
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Detailed description
This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.
The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).
The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.
This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external microphone old | Other | Device: external microphone |
| external microphone new | Other | Device: external microphone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- experienced hearing aid user
- severe hearing loss
- willingness and interest in testing an external microphone healthy outer ear
- willingness to wear behind the ear hearing aids
- Informed Consent as documented by signature
Key exclusion criteria (3 listed)
- the audiogram is not in the fitting range of the intended hearing aid
- limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- participant is not able to describe experiences and hearing impressions
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 |
|---|---|---|
| external microphoneExternal microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise. | Device | external microphone new, external microphone old |
Primary outcome
Rating of the subjective comfort for the old and the new setting
Time frame: 6 weeks
Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)
3 secondary outcomes
Evaluation of the speech intelligibility in noise
Time frame: 2 weeks
Subjective Sound Quality rating
Time frame: 6 weeks
Subjective rating of natural sounds
Time frame: 6 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 3 Mar 2020.
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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 external microphone 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?
The sponsor lists 5 inclusion and 3 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 3 Mar 2020. 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?
Rating of the subjective comfort for the old and the new setting (time frame: 6 weeks). 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 3 Mar 2020.