Hearing LossNCT03780374
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
A study testing Phonak Audéo L2M with Sound Processing Principle 1, Phonak Audéo L2M with Sound Processing Principle 2 and Phonak Audéo L2M with Sound Processing Principle 3 in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Audéo L2M with Sound Processing Principle 1, Phonak Audéo L2M with Sound Processing Principle 2 and Phonak Audéo L2M with Sound Processing Principle 3
- 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 Dec 2018to 15 Mar 2019
- 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
- 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
- Known central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.
- Conditions
- Hearing Loss
- Being tested
- Phonak Audéo L2M with Sound Processing Principle 1, Phonak Audéo L2M with Sound Processing Principle 2, Phonak Audéo L2M with Sound Processing Principle 3
- 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 Audéo L2M with Sound Processing Principle 1Device
Compensation of a hearing loss with Sound Processing Principle 1.
Phonak Audéo L2M with Sound Processing Principle 2Device
Compensation of a hearing loss with Sound Processing Principle 2.
Phonak Audéo L2M with Sound Processing Principle 3Device
Compensation of a hearing loss with Sound Processing Principle 3.
| Study group | Role | What they receive |
|---|---|---|
| Sound Processing Principle 1 | Active comparator | Sound Processing Principle 1 will be applied in the hearing aid. Receives: Device: Phonak Audéo L2M with Sound Processing Principle 1 |
| Sound Processing Principle 2 | Experimental | Sound Processing Principle 2 will be applied in the hearing aid. Receives: Device: Phonak Audéo L2M with Sound Processing Principle 2 |
| Sound Processing Principle 3 | Experimental | Sound Processing Principle 3 will be applied in the hearing aid. Receives: Device: Phonak Audéo L2M with Sound Processing Principle 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility in Noise
The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).
Measured: 4 weeks
Secondary outcomes (9)
Sound Quality - Overall
The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent).
Measured: 16 weeks
Loudness - Laboratory
The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test.
The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud).
Measured: 8 weeks
Loudness - Daily Life
The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud).
Measured: 16 weeks
Clarity - Daily Life
The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear).
Measured: 16 weeks
Preferred Sound Processing Principle
The preferred sound processing principle will be assessed with the aid of a questionnaire.
The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred).
Measured: 16 weeks
Naturalness - Daily Life
The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural).
Measured: 16 weeks
Localization - Daily Life
The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable).
Measured: 16 weeks
Reverberation - Daily Life
The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant).
Measured: 16 weeks
Satisfaction - Overall in Daily Life
The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start3 Dec 2018
- Primary completion15 Jan 2019
- Study completion15 Mar 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
- 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
- NCT03780374
- Sponsor's protocol ID
- Sonova2018_37
- Status last verified
- May 2019
- First submitted
- 30 Nov 2018
- Last updated
- 9 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
- ClinicalTrials.gov ID
- NCT03780374
- Acronym / sponsor ID
- Sonova2018_37
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 19 Dec 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.
A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
| Arm | Type | Receives |
|---|---|---|
| Sound Processing Principle 1 | Active comparator | Device: Phonak Audéo L2M with Sound Processing Principle 1Sound Processing Principle 1 will be applied in the hearing aid. |
| Sound Processing Principle 2 | Experimental | Device: Phonak Audéo L2M with Sound Processing Principle 2Sound Processing Principle 2 will be applied in the hearing aid. |
| Sound Processing Principle 3 | Experimental | Device: Phonak Audéo L2M with Sound Processing Principle 3Sound Processing Principle 3 will be applied in the hearing aid. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
- 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 Audéo L2M with Sound Processing Principle 1Compensation of a hearing loss with Sound Processing Principle 1. | Device | Sound Processing Principle 1 |
| Phonak Audéo L2M with Sound Processing Principle 2Compensation of a hearing loss with Sound Processing Principle 2. | Device | Sound Processing Principle 2 |
| Phonak Audéo L2M with Sound Processing Principle 3Compensation of a hearing loss with Sound Processing Principle 3. | Device | Sound Processing Principle 3 |
Primary outcome
Speech Intelligibility in Noise
Time frame: 4 weeks
The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).
9 secondary outcomes
Sound Quality - Overall
Time frame: 16 weeks
Loudness - Laboratory
Time frame: 8 weeks
Loudness - Daily Life
Time frame: 16 weeks
Clarity - Daily Life
Time frame: 16 weeks
Preferred Sound Processing Principle
Time frame: 16 weeks
Naturalness - Daily Life
Time frame: 16 weeks
Localization - Daily Life
Time frame: 16 weeks
Reverberation - Daily Life
Time frame: 16 weeks
Satisfaction - Overall in Daily Life
Time frame: 16 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 9 May 2019.
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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 Phonak Audéo L2M with Sound Processing Principle 1, Phonak Audéo L2M with Sound Processing Principle 2 and Phonak Audéo L2M with Sound Processing Principle 3 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 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 9 May 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?
Speech Intelligibility in Noise (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 9 May 2019.