Hearing LossNCT03718975
Quality Control of CE-Certified Phonak Hearing Aids - 2018_28
A study testing Successor of Phonak Audéo B90 and Phonak Audéo B90 in people with Hearing Loss and Sensorineural Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
Phonak Hearing Systems pass through different development and study stages. 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 to 99 years
- Conditions the study is for
- Hearing Loss, Sensorineural Hearing Loss
- What is being tested?
- Successor of Phonak Audéo B90 and Phonak Audéo B90
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2018to 23 Dec 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- willingness to wear Receiver in the canal hearing aids
- Informed Consent as documented by signature
- owning a compatible smartphone
Who cannot join
- 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 weekly appointments in Stäfa (Switzerland)
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Known psychological problems
- Central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Phonak Hearing Systems pass through different development and study stages. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized 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
In this study a comparison with two CE-labeled Phonak Receiver-in-the-canal (RIC) devices is done. The experimental device and the active comparator will be compared regarding Sound Quality perception and speech intelligibility in Quiet and in Noise. The experimental device contains direct connectivity functionality which will be investigated in terms of streamed Audio quality, streaming stability and Usability preferences of functions and Features which are related to direct connectivity. The active comparator device does not contain direct streaming functionality. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
- Conditions
- Hearing Loss, Sensorineural Hearing Loss
- Being tested
- Successor of Phonak Audéo B90, Phonak Audéo B90
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successor of Phonak Audéo B90Device
Successor of the most recent Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
Phonak Audéo B90Device
The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| Successor of Phonak Audéo B90 | Experimental | The successor of the Phonak Audéo B90 is a Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss. Receives: Device: Successor of Phonak Audéo B90 |
| Phonak Audéo B90 | Active comparator | The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss. Receives: Device: Phonak Audéo B90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of subjective acceptance of the default Hearing aid setting
The Primary Outcome measure of this study is the comparison of the default Hearing aid Fitting (first fit) in regard of the subjective acceptance rating between the experimental device and the active comparator (non-inferiority test design). The first fit acceptance will be measured via subjective satisfaction rating of different dimensions concerning sound quality perception and loudness perception (Scale of satisfaction rating ranging from 0% to 100%).
Measured: 10 weeks
Secondary outcomes (1)
Subjective Sound Quality rating of streamed telephone call (experimental device only)
The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the streamed telephone signal, which will be streamed between a smartphone and the experimental device.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start10 Sep 2018
- Primary completion23 Nov 2018
- Study completion23 Dec 2018
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
- None (open label)
- Enrolment
- 28 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
- NCT03718975
- Sponsor's protocol ID
- Sonova2018_28
- Status last verified
- Dec 2019
- First submitted
- 23 Oct 2018
- Last updated
- 5 Dec 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 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of CE-Certified Phonak Hearing Aids - 2018_28
- ClinicalTrials.gov ID
- NCT03718975
- Acronym / sponsor ID
- Sonova2018_28
- Conditions
- Hearing Loss, Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 25 Oct 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.
Phonak Hearing Systems pass through different development and study stages. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized 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
In this study a comparison with two CE-labeled Phonak Receiver-in-the-canal (RIC) devices is done. The experimental device and the active comparator will be compared regarding Sound Quality perception and speech intelligibility in Quiet and in Noise. The experimental device contains direct connectivity functionality which will be investigated in terms of streamed Audio quality, streaming stability and Usability preferences of functions and Features which are related to direct connectivity. The active comparator device does not contain direct streaming functionality. 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successor of Phonak Audéo B90 | Experimental | Device: Successor of Phonak Audéo B90The successor of the Phonak Audéo B90 is a Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss. |
| Phonak Audéo B90 | Active comparator | Device: Phonak Audéo B90The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- willingness to wear Receiver in the canal hearing aids
Key exclusion criteria (6 listed)
- 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 weekly appointments in Stäfa (Switzerland)
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Known psychological problems
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 |
|---|---|---|
| Successor of Phonak Audéo B90Successor of the most recent Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss. | Device | Successor of Phonak Audéo B90 |
| Phonak Audéo B90The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss. | Device | Phonak Audéo B90 |
Primary outcome
Evaluation of subjective acceptance of the default Hearing aid setting
Time frame: 10 weeks
The Primary Outcome measure of this study is the comparison of the default Hearing aid Fitting (first fit) in regard of the subjective acceptance rating between the experimental device and the active comparator (non-inferiority test design). The first fit acceptance will be measured via subjective satisfaction rating of different dimensions concerning sound quality perception and loudness perception (Scale of satisfaction rating ranging from 0% to 100%).
1 secondary outcome
Subjective Sound Quality rating of streamed telephone call (experimental device only)
Time frame: 10 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 5 Dec 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 Successor of Phonak Audéo B90 and Phonak Audéo B90 in people with Hearing Loss and Sensorineural 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 7 inclusion and 6 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 5 Dec 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?
Evaluation of subjective acceptance of the default Hearing aid setting (time frame: 10 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 5 Dec 2019.