Hearing LossAF360NCT07224919
AutoFocus360 Sound Quality Preference and Claims Study
A study testing AutoFocus 360 and Fixed directional microphone in people with Hearing Loss, run by Jonathan Vaisberg at 1 site in Canada.
Trial summary
This study aims to generate clinical evidence to substantiate performance claims for the AutoFocus 360 feature in Sonova hearing aid products. AutoFocus 360 is designed to enhance speech intelligibility by detecting the direction of incoming speech and dynamically steering the beamformer toward the talker, regardless… 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?
- AutoFocus 360 and Fixed directional microphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2025to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults (18-99 years)
- Binaural, symmetric, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
- Fluent in English
Who cannot join
- Minors (< 18 years
- Normal hearing or hearing loss > N6 (severe)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to generate clinical evidence to substantiate performance claims for the AutoFocus 360 feature in Sonova hearing aid products. AutoFocus 360 is designed to enhance speech intelligibility by detecting the direction of incoming speech and dynamically steering the beamformer toward the talker, regardless of their position relative to the listener. Preliminary internal testing suggested potential benefits in reducing noise disturbance and improving speech clarity compared to traditional directional microphone modes, with outcomes depending on noise type, talker location, and microphone configuration. The present study will systematically evaluate sound quality and listening performance with AutoFocus 360 versus conventional fixed directional settings to support claims of improved speech understanding in noise.
Read the detailed description
Claims evidence is required for the AutoFocus 360 feature on upcoming product platforms.
AutoFocus 360 is a feature that enhances speech intelligibility by detecting the direction from where speech is coming from relative to the hearing aid wearer and steering the beamforming towards the direction of the speech. Informal exploratory testing by normal hearing Sonova employees have identified that AutoFocus 360 reduces noise disturbance and improves speech clarity, over other microphones modes with some dependencies on (1) noise type, (2) talker location and (3) specific mode comparisons.
AutoFocus 360 is intended to improve listening by directing the hearing aid beamformer towards the speaker wherever they are relative to the listener (i.e. front, side or rear) compared to other in-noise beamforming, mainly fixed wide directional. Sonova currently does not have any data to support this. Therefore, this study will aim to produce sound quality data showing a benefit for Autofocus 360 over traditional beamforming for the purpose of claim substantiation.
- Conditions
- Hearing Loss
- Being tested
- AutoFocus 360, Fixed directional microphone
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoFocus 360Device
AutoFocus 360 is a feature that enhances speech intelligibility by detecting the direction from where speech is coming from relative to the hearing aid wearer and steering the beamforming towards the direction of the speech.
Fixed directional microphoneDevice
Fixed directional microphones delivers static beamforming towards the front of the hearing aid wearer.
| Study group | Role | What they receive |
|---|---|---|
| Participant group | Experimental | Participants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters. Receives: Device: AutoFocus 360; Device: Fixed directional microphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noise Disturbance Sound Quality Attribute
Participants will complete an A-B paired-comparison listening task to assess subjective preference for noise disturbance between two hearing aid conditions. In other words, participants will be asked "which sample has less disturbing noise". During testing, participants will listen to short audio recordings that vary in talker location and noise type. For each trial, participants will indicate which of the two recordings (A or B) has less bothersome background noise. The outcome measure will be the the percentage of "A preferred" versus "B preferred" responses aggregated across all trials and participants for a given noise and talker location. In other words, for a single noise x talker location combination, the outcome measures for AF360 and FWD should add up to 100. Binary preference data will be analyzed using inferential statistics.
Measured: During a single 2-hour onsite study session
Secondary outcomes (1)
Speech Clarity Sound Quality Attribute
Participants will complete an A-B paired-comparison listening task to assess subjective preference for speech clarity between two hearing aid conditions. In other words, participants will be asked "which sample has clearer speech". During testing, participants will listen to short audio recordings that vary in talker location and noise type. For each trial, participants will indicate which of the two recordings (A or B) has clearer speech. The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants for a given noise and talker location. In other words, for a single noise x talker location combination, the outcome measures for AF360 and FWD should add up to 100. . Binary preference data will be analyzed using inferential statistics.
Measured: During a single 2-hour onsite study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start27 Nov 2025
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Vaisberg
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Jonathan Vaisberg, Sonova AG
- Investigators
- Jinyu Qian, PhD, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224919
- Sponsor's protocol ID
- SRF-34243
- Acronym
- AF360
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2025
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AutoFocus360 Sound Quality Preference and Claims Study
- ClinicalTrials.gov ID
- NCT07224919
- Acronym / sponsor ID
- AF360 / SRF-34243
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jonathan VaisbergIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 5 Nov 2025 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to generate clinical evidence to substantiate performance claims for the AutoFocus 360 feature in Sonova hearing aid products. AutoFocus 360 is designed to enhance speech intelligibility by detecting the direction of incoming speech and dynamically steering the beamformer toward the talker, regardless of their position relative to the listener. Preliminary internal testing suggested potential benefits in reducing noise disturbance and improving speech clarity compared to traditional directional microphone modes, with outcomes depending on noise type, talker location, and microphone configuration. The present study will systematically evaluate sound quality and listening performance with AutoFocus 360 versus conventional fixed directional settings to support claims of improved speech understanding in noise.
Detailed description
Claims evidence is required for the AutoFocus 360 feature on upcoming product platforms.
AutoFocus 360 is a feature that enhances speech intelligibility by detecting the direction from where speech is coming from relative to the hearing aid wearer and steering the beamforming towards the direction of the speech. Informal exploratory testing by normal hearing Sonova employees have identified that AutoFocus 360 reduces noise disturbance and improves speech clarity, over other microphones modes with some dependencies on (1) noise type, (2) talker location and (3) specific mode comparisons.
AutoFocus 360 is intended to improve listening by directing the hearing aid beamformer towards the speaker wherever they are relative to the listener (i.e. front, side or rear) compared to other in-noise beamforming, mainly fixed wide directional. Sonova currently does not have any data to support this. Therefore, this study will aim to produce sound quality data showing a benefit for Autofocus 360 over traditional beamforming for the purpose of claim substantiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant group | Experimental | Device: AutoFocus 360, Device: Fixed directional microphoneParticipants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18-99 years)
- Binaural, symmetric, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
- Fluent in English
Key exclusion criteria (2 listed)
- Minors (< 18 years
- Normal hearing or hearing loss > N6 (severe)
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 |
|---|---|---|
| AutoFocus 360AutoFocus 360 is a feature that enhances speech intelligibility by detecting the direction from where speech is coming from relative to the hearing aid wearer and steering the beamforming towards the direction of the speech. | Device | Participant group |
| Fixed directional microphoneFixed directional microphones delivers static beamforming towards the front of the hearing aid wearer. | Device | Participant group |
Primary outcome
Noise Disturbance Sound Quality Attribute
Time frame: During a single 2-hour onsite study session
Participants will complete an A-B paired-comparison listening task to assess subjective preference for noise disturbance between two hearing aid conditions. In other words, participants will be asked "which sample has less disturbing noise". During testing, participants will listen to short audio recordings that vary in talker location and noise type. For each trial, participants will indicate which of the two recordings (A or B) has less bothersome background noise. The outcome measure will be the the percentage of "A preferred" versus "B preferred" responses aggregated across all trials and participants for a given noise and talker location. In other words, for a single noise x talker location combination, the outcome measures for AF360 and FWD should add up to 100. Binary preference data will be analyzed using inferential statistics.
1 secondary outcome
Speech Clarity Sound Quality Attribute
Time frame: During a single 2-hour onsite study session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jinyu Qian, PhD 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 AutoFocus 360 and Fixed directional microphone in people with Hearing Loss, run by Jonathan Vaisberg at 1 site in Canada.
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 2 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 10 Aug 2026. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Noise Disturbance Sound Quality Attribute (time frame: During a single 2-hour onsite study session). 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 10 Aug 2026.