Hearing LossNCT04496791
Quality Control of CE-Certified Phonak Hearing Aids - 2020_26
A study testing RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) 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?
- RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)
- 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
- 1 Jun 2020to 7 Aug 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
- Hearing Loss range: N3-N4
- experienced hearing aid user
- 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
- first time user
- limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- participant is not able to describe experiences and hearing impressions
- allergies against the material of the hearing aid
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 Canal) hearing aid/ hearing instrument (HI)
- 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 Canal) hearing aid/ hearing instrument (HI)Device
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 instrument (HI) with modified precalculation. Receives: Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) |
| Phonak Audéo M-90 | Active comparator | Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss. Receives: Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) |
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 HI
Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
Measured: 4 weeks
Secondary outcomes (4)
Speech intelligibility in noisy situations (only test device)
Evaluating the speech intelligibility with the test device, using a speech in noise test, Oldenburger Satztest (OLSA) after the subject set the noise cancellation via an App on an individual limit. The results of the test are the word recognition score in SNR.
Measured: 4 week
Speech intelligibility in quiet situations
Evaluating and comparing the speech intelligibility in a quiet test situation of the test device and the Marvel device. Using the "Reimtest nach Wallenberg und Kollmeier (WaKo ) (%).
Measured: 4 week
Speech intelligibility in noisy situations
Evaluating and comparing the speech intelligibility in a noisy test situation of the test device and competitor. Using the OLSA (word recognition score)
Measured: 4 weeks
Rating of sound quality
Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after the First Fit. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
Measured: 1 week
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 start1 Jun 2020
- Primary completion7 Aug 2020
- Study completion7 Aug 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
- 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
- NCT04496791
- Sponsor's protocol ID
- Sonova2020_26
- Status last verified
- Sep 2020
- First submitted
- 29 Jul 2020
- Last updated
- 10 Sep 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 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of CE-Certified Phonak Hearing Aids - 2020_26
- ClinicalTrials.gov ID
- NCT04496791
- Acronym / sponsor ID
- Sonova2020_26
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 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 Canal) hearing aid/ hearing instrument (HI)Phonak Hearing instrument (HI) with modified precalculation. |
| Phonak Audéo M-90 | Active comparator | Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hearing Loss range: N3-N4
- experienced hearing aid user
- willingness to wear behind the ear hearing aids
- Informed Consent as documented by signature
Key exclusion criteria (5 listed)
- the audiogram is not in the fitting range of the intended hearing aid
- first time user
- limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- participant is not able to describe experiences and hearing impressions
- allergies against the material of the hearing aid
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 Canal) hearing aid/ hearing instrument (HI)HI 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 HI
Time frame: 4 weeks
Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
4 secondary outcomes
Speech intelligibility in noisy situations (only test device)
Time frame: 4 week
Speech intelligibility in quiet situations
Time frame: 4 week
Speech intelligibility in noisy situations
Time frame: 4 weeks
Rating of sound quality
Time frame: 1 week
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 10 Sep 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 RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) 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 4 inclusion and 5 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 10 Sep 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 sound quality for the new and the comparative HI (time frame: 4 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 10 Sep 2020.