AutoFocus360 Sound Quality Preference and Claims Study

NCT ID: NCT07224919

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-05-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AutoFocus 360

Intervention Type: 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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Fixed directional microphone

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonathan Vaisberg

INDUSTRY

Sponsor Role: lead

Responsible Party

Jonathan Vaisberg

Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jinyu Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Central Contacts

Jonathan M Vaisberg, PhD

Role: CONTACT

jonathan.vaisberg@sonova.com

905-745-6785

Other Identifiers

SRF-34243

Identifier Type: -

Identifier Source: org_study_id