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Completed

NCT Number: NCT07224919

AutoFocus360 Sound Quality Preference and Claims 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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova Canada Inc.

Kitchener, Ontario, N2E 1Y6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AutoFocus 360

Device

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 microphone

Device

Fixed directional microphones delivers static beamforming towards the front of the hearing aid wearer.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Jonathan Vaisberg

Industry

Registry information

Acronym: AF360

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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