Hearing LossNCT04018911
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20
A study testing Hearing Aid with standard Noise Reduction (NR_1), Hearing Aid with NR_2 and Hearing Aid with NR_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 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 with standard Noise Reduction (NR_1), Hearing Aid with NR_2 and Hearing Aid with NR_3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jun 2019to 16 Sep 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
- 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 with standard Noise Reduction (NR_1), Hearing Aid with NR_2, Hearing Aid with NR_3, Hearing Aid with NR_4
- 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 with standard Noise Reduction (NR_1)Device
Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.
Hearing Aid with NR_2Device
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 (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_3Device
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 (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_4Drug
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. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid standard NR_1 | Active comparator | Hearing Aid with standard Noise Reduction (NR) serves as reference condition. Receives: Device: Hearing Aid with standard Noise Reduction (NR_1) |
| Hearing Aid with NR_2 | Experimental | NR_2: Noise Reduction principle 2 Receives: Device: Hearing Aid with NR_2 |
| Hearing Aid with NR_3 | Experimental | NR_3: Noise Reduction principle 3 Receives: Device: Hearing Aid with NR_3 |
| Hearing Aid with NR_4 | Experimental | NR_4: Noise Reduction principle 4 Receives: Drug: Hearing Aid with NR_4 |
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 & reaction time 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 press a button as fast as possible when a light appears on a screen as a secondary task. The aim is to recall as many words from the presented sentence at a predefined SNR and press the button as fast as possible at the same time. The data derived, serving as secondary outcome measure are he Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached and the reaction time (RT) in seconds and the number of missed stimuli. and number of false alarms missed data rate.
Measured: 3 weeks
Oldenburg Sentence test (Olsa)
Oldenburg Sentence test in noise will be administered as single task. The aim is to recall as many words from the presented sentence at different signal to noise ratios until the 50% threshold is reached. The data derived, serving as secondary outcome measure are the Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached.
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: 3 weeks
qualitative interview form
A qualitative questionnaire with predefined questions and comment sections to gather information on individual perceptions regarding the 3 experimental conditions to the active comparator ( see study arms/ interventions for detailed descriptions) during different laboratory-based complex acoustic scenes. The data collected from this questionnaire are scores on a continuous rating scale ranging from "0" (worst) to "10"( best).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start3 Jun 2019
- Primary completion19 Aug 2019
- Study completion16 Sep 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 each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 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
- NCT04018911
- Sponsor's protocol ID
- Sonova2019_20
- Status last verified
- Oct 2019
- First submitted
- 20 Jun 2019
- Last updated
- 11 Oct 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 11 Oct 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
- NCT04018911
- Acronym / sponsor ID
- Sonova2019_20
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 15 Jul 2019 (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 standard NR_1 | Active comparator | Device: Hearing Aid with standard Noise Reduction (NR_1)Hearing Aid with standard Noise Reduction (NR) serves as reference condition. |
| Hearing Aid with NR_2 | Experimental | Device: Hearing Aid with NR_2NR_2: Noise Reduction principle 2 |
| Hearing Aid with NR_3 | Experimental | Device: Hearing Aid with NR_3NR_3: Noise Reduction principle 3 |
| Hearing Aid with NR_4 | Experimental | Drug: Hearing Aid with NR_4NR_4: Noise Reduction principle 4 |
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
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 with standard Noise Reduction (NR_1)Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle. | Device | Hearing Aid standard NR_1 |
| Hearing Aid with NR_2Each 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 (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_2 |
| Hearing Aid with NR_3Each 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 (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_3 |
| Hearing Aid with NR_4Each 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. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality. | Drug | Hearing Aid with NR_4 |
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 & reaction time task
Time frame: 3 weeks
Oldenburg Sentence test (Olsa)
Time frame: 4 weeks
Adaptive Categorial Listening Effort Scaling (ACALES)
Time frame: 3 weeks
qualitative interview form
Time frame: 3 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 11 Oct 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.
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 with standard Noise Reduction (NR_1), Hearing Aid with NR_2 and Hearing Aid with NR_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 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 11 Oct 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?
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 11 Oct 2019.