Clinical trial NCT05284903: Hearing Aid Performance Study for Different Spatial Configurations
Official title: Hearing Aid Performance Study for Different Spatial Configurations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Speech reception threshold (SRT) for Beamformer Benefit (Oldenburg Sentence Test)
timeFrame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Secondary outcomes:
measure: Listening Effort for Beamformer Benefit (ACALES)
timeFrame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
measure: Listening effort for SE benefit (ACALES)
timeFrame: At the test appointment, maximum duration of the test is 120 minutes
measure: Speech Intelligibility for SE benefit (Oldenburg Sentence Test)
timeFrame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
measure: Subjective Perception, Subjective Assessment for SE benefit (Questionnaire)
timeFrame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
measure: Speech reception threshold (SRT) for Hearing Aid Benefit (Oldenburg Sentence Test)
timeFrame: At the test appointment, maximum duration of the test is 120 minutes
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hörzentrum Oldenburg gGmbH
state: Niedersachsen
Study officials:
References: