Hearing Loss, Bilateral Sensorineural, ProgressiveNCT03108768
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
A study testing Hearing Aid (Successor of Phonak Virto V) and Hearing Aid (Phonak Virto V) in people with Hearing Loss, Bilateral Sensorineural, Progressive, run by Sonova AG at 1 site in Switzerland.
Trial summary
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss, Bilateral Sensorineural, Progressive
- What is being tested?
- Hearing Aid (Successor of Phonak Virto V) and Hearing Aid (Phonak Virto V)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Apr 2017to 14 Jun 2017
- 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) with and without (experience with) hearing aids
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Informed Consent as documented by signature
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
- Massively limited dexterity
- Known psychological problems
- Central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.
Read the detailed description
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 in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
- Being tested
- Hearing Aid (Successor of Phonak Virto V), Hearing Aid (Phonak Virto V)
- 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 (Successor of Phonak Virto V)Device
The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
Hearing Aid (Phonak Virto V)Device
Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| Successor of Phonak Virto V | Experimental | The successor of Phonak's Virto V will be fitted to the participants individual hearing loss. Receives: Device: Hearing Aid (Successor of Phonak Virto V) |
| Phonak Virto V | Active comparator | Phonak Virto V will be fitted to the participants individual hearing loss. Receives: Device: Hearing Aid (Phonak Virto V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Measured: Three weeks
Secondary outcomes (2)
Speech intelligibility in percent in a quiet listening situation
The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the german rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Measured: One week
Zero-defect performance in daily life
The data, serving as secondary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start3 Apr 2017
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral Sensorineural, ProgressiveStudies 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
- Crossover
- Model description
- Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT03108768
- Sponsor's protocol ID
- Sonova2016_37
- Status last verified
- Jun 2017
- First submitted
- 31 Mar 2017
- Last updated
- 16 Jun 2017
- 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 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
- ClinicalTrials.gov ID
- NCT03108768
- Acronym / sponsor ID
- Sonova2016_37
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 11 Apr 2017 (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 new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.
Detailed description
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 in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
| Arm | Type | Receives |
|---|---|---|
| Successor of Phonak Virto V | Experimental | Device: Hearing Aid (Successor of Phonak Virto V)The successor of Phonak's Virto V will be fitted to the participants individual hearing loss. |
| Phonak Virto V | Active comparator | Device: Hearing Aid (Phonak Virto V)Phonak Virto V 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 (5 listed)
- Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Informed Consent as documented by signature
Key exclusion criteria (7 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
- Massively limited dexterity
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 (Successor of Phonak Virto V)The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss. | Device | Successor of Phonak Virto V |
| Hearing Aid (Phonak Virto V)Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss. | Device | Phonak Virto V |
Primary outcome
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)
Time frame: Three weeks
The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
2 secondary outcomes
Speech intelligibility in percent in a quiet listening situation
Time frame: One week
Zero-defect performance in daily life
Time frame: Three 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 16 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Bilateral Sensorineural, Progressive
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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 (Successor of Phonak Virto V) and Hearing Aid (Phonak Virto V) in people with Hearing Loss, Bilateral Sensorineural, Progressive, 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 7 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 16 Jun 2017. 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?
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR) (time frame: Three 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 16 Jun 2017.