PRINCE22 System Complete Performance Study

Sonova

Status: Completed

Conditions: Hearing Loss, Bilateral; Hearing Loss, Unilateral

Treatments: Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale); Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test); Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test); Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05656313

SRF-2391

Details and patient eligibility

About

The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.

Enrollment: 22 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 perform tests successfully
• Ability to describe listening experiences,
• Ability to attend to the appointments,
• Healthy outer ear,
• Moderat to severe Hearing
• 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: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Narrow reference beamformer

Experimental group

Treatment:

Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)

Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)

Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)

Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test)

Novel beamformer approach

Active Comparator group

Treatment:

Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)

Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)

Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)

Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test)