Hearing LossNCT04496271
Quality Control of CE-Certified Phonak Hearing Aids - 2020_06
A study testing RIC (Receiver in channel)- device 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 50 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- RIC (Receiver in channel)- device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jan 2020to 8 Apr 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported confidence to using Bluetooth smartphone
- Hearing Loss range: moderate and moderate/ severe
- experienced hearing aid user
- willingness and interest in testing new features
- 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
- participant has finger movement disorders
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 investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.
- Conditions
- Hearing Loss
- Being tested
- RIC (Receiver in channel)- device
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIC (Receiver in channel)- deviceDevice
HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication
| Study group | Role | What they receive |
|---|---|---|
| Successor of Phonak Audéo M-90 | Experimental | Phonak Hearing aid with modified precalculation. Receives: Device: RIC (Receiver in channel)- device |
| Phonak Audéo M-90 | Active comparator | Phonak Audéo M-90 is the most recent Receiver In Canal hearing aid by Phonak which will be fitted to the participants individual hearing loss. Receives: Device: RIC (Receiver in channel)- device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of the sound quality for the new and the comparative Hearing aid
Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
Measured: 5 weeks
Secondary outcomes (2)
Rating sound quality of own voice
Evaluating subjectively the HI regarding to the naturalness of the own voice. Participant will be ask in the first visit for spontaneous acceptance, regarding to the quality of their own voice, by rating scales. They have to rate the clarity, dullness etc. of their own voice. Also they will be ask after the hometrial how satisfy they are with the sound quality of their own voice.They have to rate it by rating scales in percentage. (e.g. very satisfy = 100%, very unsatisfy = 0%)
Measured: 5 weeks
Evaluating listening effort
Evaluating listening effort by a special feature. The participants will be in a noisy test situation and have to listen to words, which they should repeat. After each group of words they will be ask to rate how difficult it was to understand by a rating scala (very difficult-difficult-somewhat-easy-very easy). The participants have to do that with the new and the old RIC device. The test will be randomized and single blinded.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start13 Jan 2020
- Primary completion16 Mar 2020
- Study completion8 Apr 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
- 23 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
- NCT04496271
- Sponsor's protocol ID
- Sonova2020_06
- Status last verified
- Apr 2020
- First submitted
- 28 Feb 2020
- Last updated
- 28 Nov 2022
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of CE-Certified Phonak Hearing Aids - 2020_06
- ClinicalTrials.gov ID
- NCT04496271
- Acronym / sponsor ID
- Sonova2020_06
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 3 Aug 2020 (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 investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successor of Phonak Audéo M-90 | Experimental | Device: RIC (Receiver in channel)- devicePhonak Hearing aid with modified precalculation. |
| Phonak Audéo M-90 | Active comparator | Device: RIC (Receiver in channel)- devicePhonak Audéo M-90 is the most recent Receiver In Canal hearing aid by Phonak which will be fitted to the participants individual hearing loss. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-reported confidence to using Bluetooth smartphone
- Hearing Loss range: moderate and moderate/ severe
- experienced hearing aid user
- willingness and interest in testing new features
- willingness to wear behind the ear hearing aids
Key exclusion criteria (4 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
- participant has finger movement disorders
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 |
|---|---|---|
| RIC (Receiver in channel)- deviceHI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication | Device | Phonak Audéo M-90, Successor of Phonak Audéo M-90 |
Primary outcome
Rating of the sound quality for the new and the comparative Hearing aid
Time frame: 5 weeks
Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
2 secondary outcomes
Rating sound quality of own voice
Time frame: 5 weeks
Evaluating listening effort
Time frame: 5 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 28 Nov 2022.
- 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 RIC (Receiver in channel)- device 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 6 inclusion and 4 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 28 Nov 2022. 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 sound quality for the new and the comparative Hearing aid (time frame: 5 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 28 Nov 2022.