Hearing LossNCT02754843
Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)
A study testing Phonak's equivalent newly developped power BTE and Equivalent competitor device in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch. 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?
- Phonak's equivalent newly developped power BTE and Equivalent competitor device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Jan 2016
- 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 impaired persons with and without (experience with) hearing aids
- Good written and spoken (Swiss) German language skills
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Who cannot join
- Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- 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
The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.
- Conditions
- Hearing Loss
- Being tested
- Phonak's equivalent newly developped power BTE, Equivalent competitor 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.
Phonak's equivalent newly developped power BTEDevice
Equivalent competitor deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Naida Q90-SP | Active comparator | Phonak's commercial power Behind-The-Ear (BTE) device, type 1. Receives: Device: Phonak's equivalent newly developped power BTE; Device: Equivalent competitor device |
| Naida Q90-UP | Active comparator | Phonak's commercial power Behind-The-Ear (BTE) device, type 2. Receives: Device: Phonak's equivalent newly developped power BTE; Device: Equivalent competitor device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility in quiet. Discrimination [%]
The data, serving as primary outcome, 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.
Speech intelligibility in noise. Speech Reception Threshold [dB SNR]
The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the German Oldenburger sentence test. The result is the Speech Reception Threshold [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: One week.
Secondary outcomes (4)
Phoneme Perception Test, test no. 1.
Free field audiometry using narrow band high frequency signals to measure detection thresholds [dB]. 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: Four weeks
Phoneme Perception Test, test no. 2.
Free field audiometry using high frequency phonemes to capture their recognition thresholds [dB]. 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: Four weeks
Phoneme Perception Test, test no. 3.
Free field audiometry using high frequency phonemes to capture the subjects' distinction capabilities [confusion matrix]. 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: Four weeks
Diary to describe hearing impressions in everyday life
Subjects are asked to describe their subjective experiences in different listening situations, in daily life, with the aid of quantitative questionnaires. the results are "Yes/No" replies and open-ended.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2016
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simone Ebbing, B.Sc., Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754843
- Sponsor's protocol ID
- Sonova2015-00
- Status last verified
- Apr 2016
- First submitted
- 16 Oct 2015
- Last updated
- 28 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)
- ClinicalTrials.gov ID
- NCT02754843
- Acronym / sponsor ID
- Sonova2015-00
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naida Q90-SP | Active comparator | Device: Phonak's equivalent newly developped power BTE, Device: Equivalent competitor devicePhonak's commercial power Behind-The-Ear (BTE) device, type 1. |
| Naida Q90-UP | Active comparator | Device: Phonak's equivalent newly developped power BTE, Device: Equivalent competitor devicePhonak's commercial power Behind-The-Ear (BTE) device, type 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hearing impaired persons with and without (experience with) hearing aids
- Good written and spoken (Swiss) German language skills
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Key exclusion criteria (7 listed)
- Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- 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 |
|---|---|---|
| Phonak's equivalent newly developped power BTE | Device | Naida Q90-SP, Naida Q90-UP |
| Equivalent competitor device | Device | Naida Q90-SP, Naida Q90-UP |
Primary outcome
Speech intelligibility in quiet. Discrimination [%]
Time frame: One week.
The data, serving as primary outcome, 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.
Speech intelligibility in noise. Speech Reception Threshold [dB SNR]
Time frame: One week.
The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the German Oldenburger sentence test. The result is the Speech Reception Threshold [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.
4 secondary outcomes
Phoneme Perception Test, test no. 1.
Time frame: Four weeks
Phoneme Perception Test, test no. 2.
Time frame: Four weeks
Phoneme Perception Test, test no. 3.
Time frame: Four weeks
Diary to describe hearing impressions in everyday life
Time frame: Six 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 Apr 2016.
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
Simone Ebbing, B.Sc. principal investigator
Sonova AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonak's equivalent newly developped power BTE and Equivalent competitor 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 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 28 Apr 2016. 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 quiet. Discrimination [%] (time frame: One week.). The study lists 2 primary outcomes in all. 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 Apr 2016.