Hearing Aid Performance Study for Different Spatial Configurations

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility; Other: Hearing aid benefit: Speech intelligibility in noise (aided condition); Other: Beamformer Benefit: Speech intelligibility and Listening effort; Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05284903

SRF-386

Details and patient eligibility

About

This clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from Phonak). The clinical investigation is divided in three parts addressing different challenges met by hearing aid users.

Full description

Hearing aids are designed to amplify and transmit sound to compensate for impaired hearing. The main objective of this medical device is to improve the perception of speech, which can be defined among many attributes by intelligibility or listening effort. Evaluating the performance of the hearing aid or different features reasonably assumes that the talker location should be in front and close of the hearing aid user. However, listening situations in daily life might show much more variability regarding the spatial configuration of the talker, listener and noise sources.

This investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. The investigational device is European conformity (CE) marked and will be used within its defined use and on the intended population. The investigation is divided into three independent parts:

• Beamformer (BF) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer,
• Speech Enhancer benefit: the second part of the study will evaluate the effect of the Speech Enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility,
• Hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Experienced (minimum use duration 6 months)
• Adult (minimum age: 18 years) hearing aid users,
• Written and spoken German,
• Ability to understand instruction,
• Ability to describe listening experiences,
• Ability to attend to the appointments,
• Healthy outer ear,
• Hearing loss within the fitting ranges of the investigational product,
• Informed consent as documented by signature.

Exclusion criteria

• Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
• Known hypersensitivity or allergy,
• Not willing to wear the hearing aid,
• Fluctuating hearing that could influence the results.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Experimental: Phonak device with activated feature

Other group

Description:

The clinical investigation is designed to evaluate clinical performances in terms of speech intelligibility and listening effort. The expected benefit is based on clinical relevant differences. This clinical investigation is divided in three parts including Beamformer benefit, Speech Enhancer benefit and Hearing aid benefit (this part will be performed aided).

Treatment:

Other: Beamformer Benefit: Speech intelligibility and Listening effort

Other: Hearing aid benefit: Speech intelligibility in noise (aided condition)

Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)

Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility

Comparator: Phonak device with deactivated feature

Other group

Description:

The comparative testings should be used as reference. The measures will be performed by the same participant group and the same three parts will be evaluated including Beamformer (BF) benefit, Speech Enhancer benefit and Hearing aid benefit. The reference will be performed without these features or with different settings of these features. In case of the Hearing aid benefit, the reference is an unaided fitting.

Treatment:

Other: Beamformer Benefit: Speech intelligibility and Listening effort

Other: Hearing aid benefit: Speech intelligibility in noise (aided condition)

Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)

Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility