AutoFocus360 Sound Quality Preference and Claims Study (AF360)

April 15, 2026 updated by: Jonathan Vaisberg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2E 1Y6
        • Sonova Canada Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (18-99 years)
  • Binaural, symmetric, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
  • Fluent in English

Exclusion Criteria:

  • Minors (< 18 years
  • Normal hearing or hearing loss > N6 (severe)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participant group
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.
Device: AutoFocus 360
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.
Device: Fixed directional microphone
Fixed directional microphones delivers static beamforming towards the front of the hearing aid wearer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. 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 proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants. Binary preference data will be analyzed using inferential statistics.
During a single 2-hour onsite study session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech clarity 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 speech clarity between two hearing aid conditions. 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. Binary preference data will be analyzed using inferential statistics.
During a single 2-hour onsite study session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonathan Vaisberg

Investigators

  • Principal Investigator: Jinyu Qian, PhD, Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2025

Primary Completion (Actual)

March 19, 2026

Study Completion (Actual)

March 19, 2026

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-34243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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