Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility

Sebastian Griepentrog

Status: Begins enrollment in 1 month

Conditions: Hearing Loss

Treatments: Device: Hearing aid with gain precalculation principle 2; Device: Hearing aid with gain precalculation principle 1; Device: Competitor device, hearing aid with standard gain precalculation principle

Study type: Interventional

Funder types: Industry

Identifiers

NCT07388784

SRF-35145

Details and patient eligibility

About

An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hearing impaired adult at a minimum age of 18 years
• Good written and spoken german skills
• Ability to fill in a questionnaire concientiously
• Ability to produce a reliable hearing test result
• Ability to describe listening impressions / experiences
• Audiogram is in the fitting range of the hearing aids

Exclusion criteria

• Unaidable hearing loss in one or both ears
• Auricle deformities that prevent secure placement of the investigational device
• Acute tinnitus in one or both ears
• Unwillingness to test the investigational device
• Asymmetrical hearing loss
• Hypersensitivity or allergy against synthetic materials
• Symptoms of vertigo or dizziness
• Suffering from any otologic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups

Competitor device, hearing aid with standard gain precalculation principle

Active Comparator group

Description:

Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.

Treatment:

Device: Hearing aid with gain precalculation principle 1

Device: Hearing aid with gain precalculation principle 2

Hearing aid with gain precalculation principle 1

Experimental group

Description:

Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.

Treatment:

Device: Competitor device, hearing aid with standard gain precalculation principle

Hearing aid with gain precalculation principle 2

Experimental group

Description:

Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.

Treatment:

Device: Competitor device, hearing aid with standard gain precalculation principle