AutoFocus360 Sound Quality Preference and Claims Study (AF360)

Jonathan Vaisberg

Status: Not yet enrolling

Conditions: Hearing Loss

Treatments: Device: AutoFocus 360; Device: Fixed directional microphone

Study type: Interventional

Funder types: Industry

Identifiers

NCT07224919

SRF-34243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Participant group

Experimental group

Description:

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.

Treatment:

Device: Fixed directional microphone

Device: AutoFocus 360