AutoFocus360 Sound Quality Preference and Claims Study

NCT07224919 | Completed Results DMC

• 1 other identifier: SRF-34243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  During a single 2-hour onsite study session

Secondary Outcomes (1)

• Speech Clarity Sound Quality Attribute

  During a single 2-hour onsite study session

Study Arms (1)

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.

Device: AutoFocus 360; Device: Fixed directional microphone

Interventions

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.

Participant group

Fixed directional microphone DEVICE

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

Participant group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jonathan Vaisberg: lead

Study Sites (1)

Sonova Canada Inc.

Kitchener, Ontario, N2E 1Y6, Canada

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Ten of the 30 participants completed an earlier version of the protocol whose data are not reported in the final study results. Those ten participants were enrolled in the study. However, their data were withdrawn due to their protocol no longer being valid.

Results Point of Contact

• Title: Jonathan Vaisberg
• Organization: Sonova

jonathan.vaisberg@sonova.com

905-745-6785

Study Officials

• Jinyu Qian, PhD

  Sonova AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: November 27, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: August 10, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)