Hearing Aid Performance Study for Different Spatial Configurations

NCT05284903 | Completed

• 1 other identifier: SRF-386
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Speech reception threshold (SRT) for Beamformer Benefit (Oldenburg Sentence Test)

  The measure of the speech reception threshold (SRT) is a procedure to evaluate the speech intelligibility in different listening conditions. The SRT in noise is defined as the signal-to-noise ratio (SNR) needed to understand 50% of the presented sentences. The SNR is adapted based on the intelligibility score of the previous sentence. The SRT will be measured with the Oldenburg Sentence Test (OLSA), which is a standard speech intelligibility test in German. The OLSA test uses nonsense sentences with equivalent difficulty.

  At the test and retest appointment, maximum duration of the test/retest is 120 minutes

Secondary Outcomes (5)

• Listening Effort for Beamformer Benefit (ACALES)

  At the test and retest appointment, maximum duration of the test/retest is 120 minutes

• Listening effort for SE benefit (ACALES)

  At the test appointment, maximum duration of the test is 120 minutes

• Speech Intelligibility for SE benefit (Oldenburg Sentence Test)

  At the test and retest appointment, maximum duration of the test/retest is 120 minutes

• Subjective Perception, Subjective Assessment for SE benefit (Questionnaire)

  At the test and retest appointment, maximum duration of the test/retest is 120 minutes

• Speech reception threshold (SRT) for Hearing Aid Benefit (Oldenburg Sentence Test)

  At the test appointment, maximum duration of the test is 120 minutes

Study Arms (2)

Experimental: Phonak device with activated feature

OTHER

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).

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

Comparator: Phonak device with deactivated feature

OTHER

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.

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

Interventions

Beamformer Benefit: Speech intelligibility and Listening effort OTHER

Confirm the improvement in terms of speech intelligibility (measured by OLSA, Oldenburg Sentence Test) and the reduction in terms of listening effort (measured by ACALES) of the I-BF (investigational Beamformer) compared to the R-BF (reference Beamformer), when speech is not coming from the front.

Comparator: Phonak device with deactivated feature; Experimental: Phonak device with activated feature

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

Confirm the improvement in terms of speech intelligibility (measured by Oldenburg Sentence test) and the reduction in terms of listening effort (measured by ACALES) when the Speech Enhancer is on (SE ON) compared to Speech Enhancer is off (SE OFF) for distant speech or speech from adjacent room. Confirm the improvement in terms of subjective level to follow a conversation in quiet when SE ON compared to SE OFF for distant speech or speech from adjacent room. Measured by a subjective assessment.

Comparator: Phonak device with deactivated feature; Experimental: Phonak device with activated feature

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

Confirm the improvement in terms of speech intelligibility (measured by OLSA) in noise with the investigational device (aided condition) compared to the unaided condition.

Comparator: Phonak device with deactivated feature; Experimental: Phonak device with activated feature

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

Confirm the improvement in terms of speech intelligibility (measured by OLSA) with the Reference binaural beamformer compared to the fixed directional.

Comparator: Phonak device with deactivated feature; Experimental: Phonak device with activated feature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Hörzentrum Oldenburg gGmbH

Oldenburg, Lower Saxony, 26129, Germany

Location

Related Links

• New implementation of directional beamforming configurations shows improved speech understanding and reduced listening effort

MeSH Terms

Conditions

Hearing Loss

Interventions

Listening Effort; Noise

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Auditory Perception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 17, 2022
• Study Start: March 21, 2022
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)