Hearing LossNCT03554577
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12
A study testing Hearing Aid without NR, Hearing Aid with NR_A and Hearing Aid with NR_B 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 participants. 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?
- Hearing Aid without NR, Hearing Aid with NR_A and Hearing Aid with NR_B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 May 2018to 2 Oct 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
- 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 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
- 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
- colour blinded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
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 participants. These sound changing principles are enabled by respective hearing instrument technologies and 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 randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid without NR, Hearing Aid with NR_A, Hearing Aid with NR_B, Hearing Aid with NR_C
- 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 without NRDevice
Also called NR: Noise Reduction
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_ADevice
Also called NR_A: Noise Reduction principle A
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_BDevice
Also called NR_B: Noise Reduction principle B
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_CDevice
Also called NR_C: Noise Reduction principle C
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid without NR | Active comparator | Hearing Aid without Noise Reduction (NR) serves as reference condition. Receives: Device: Hearing Aid without NR |
| Hearing Aid with NR_A | Experimental | NR_A: Noise Reduction principle A Receives: Device: Hearing Aid with NR_A |
| Hearing Aid with NR_B | Experimental | NR_B: Noise Reduction principle B. Receives: Device: Hearing Aid with NR_B |
| Hearing Aid with NR_C | Experimental | NR_C: Noise Reduction principle C. Receives: Device: Hearing Aid with NR_C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound quality ratings
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as the primary outcome measure, are collected in the laboratory and will use a continuous rating scale. The scale ranges from 0 "very bad" to 100 "very good" in increments of 1.
Measured: 4 weeks
Secondary outcomes (4)
Oldenburg sentence test in noise
The data, serving as secondary outcome is a Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached. This outcome measurement will be carried out in the laboratory.
Measured: 4 weeks
Oldenburg sentence test & manual tracking task
A dual task paradigm will be used in which the Oldenburg Sentence test in noise will be administered as a primary task, and the subject will manually track a point on a computerised elliptical track as a secondary task. The aim is to recall as many words from the presented sentence at a predefined SNR and track the point as accurately as possible at the same time. The SNR is set as the level at which a subject reaches a speech reception threshold of 80-90%. The data derived, serving as a secondary outcome measure, are a [%] of time on target and distance error from the target.
Measured: 4 weeks
Adaptive Categorial Listening Effort Scaling (ACALES)
The ACALES procedure determines self-reported individual listening effort on a scale from "extreme effort" to "no effort" within a signal-to-noise ratio range that corresponds to individual subject perceptions.
The data, serving as a secondary outcome, are a set of points on a categorial scale (subjectively perceived listening effort) as a function of different SNRs.
Measured: 2 weeks
Self-report form
A qualitative questionnaire with predefined questions and comment sections to gather information on individual perceptions regarding the comparison of two different hearing programs during different laboratory-based acoustic scenes. For details of the hearing aid settings, see study arms. The data collected from this questionnaire are scores on a continuous rating scale ranging from "hearing program A is much worse than hearing program B" to "hearing program B is much better than hearing program A" and any subjective comments given.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start28 May 2018
- Primary completion31 Aug 2018
- Study completion2 Oct 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juliane Raether, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554577
- Sponsor's protocol ID
- Sonova2018_12
- Status last verified
- Nov 2018
- First submitted
- 7 May 2018
- Last updated
- 16 Nov 2018
- 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 Nov 2018. 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
- NCT03554577
- Acronym / sponsor ID
- Sonova2018_12
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 13 Jun 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 participants. These sound changing principles are enabled by respective hearing instrument technologies and 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 randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid without NR | Active comparator | Device: Hearing Aid without NRHearing Aid without Noise Reduction (NR) serves as reference condition. |
| Hearing Aid with NR_A | Experimental | Device: Hearing Aid with NR_ANR_A: Noise Reduction principle A |
| Hearing Aid with NR_B | Experimental | Device: Hearing Aid with NR_BNR_B: Noise Reduction principle B. |
| Hearing Aid with NR_C | Experimental | Device: Hearing Aid with NR_CNR_C: Noise Reduction principle C. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Key exclusion criteria (8 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
- 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 without NRAlso: NR: Noise ReductionEach participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid without NR |
| Hearing Aid with NR_AAlso: NR_A: Noise Reduction principle AEach participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_A |
| Hearing Aid with NR_BAlso: NR_B: Noise Reduction principle BEach participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_B |
| Hearing Aid with NR_CAlso: NR_C: Noise Reduction principle CEach participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_C |
Primary outcome
Sound quality ratings
Time frame: 4 weeks
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as the primary outcome measure, are collected in the laboratory and will use a continuous rating scale. The scale ranges from 0 "very bad" to 100 "very good" in increments of 1.
4 secondary outcomes
Oldenburg sentence test in noise
Time frame: 4 weeks
Oldenburg sentence test & manual tracking task
Time frame: 4 weeks
Adaptive Categorial Listening Effort Scaling (ACALES)
Time frame: 2 weeks
Self-report form
Time frame: One 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 16 Nov 2018.
- 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.
Juliane Raether 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 Hearing Aid without NR, Hearing Aid with NR_A and Hearing Aid with NR_B 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 3 inclusion and 8 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 Nov 2018. 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?
Sound quality ratings (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 16 Nov 2018.