Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Hearing Aid with NR(1); Device: Hearing Aid with NR(2); Device: Hearing Aid without NR enabled; Device: Hearing Aid with NR(3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04578457

Sonova2020_09

Details and patient eligibility

About

Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort & performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.

Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.

Enrollment: 19 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy outer ear (without previous surgical procedures)
• Ability to fill in a questionnaire conscientiously
• Informed Consent as documented by signature
• Minimum 1 year hearing aid experience
• Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion criteria

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
• Limited mobility and not in the position to attend weekly appointments
• Inability to produce a reliable hearing test result
• Massively limited dexterity
• Known psychological problems
• Known central hearing disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 4 patient groups

Hearing Aid without NR(0) enabled

Active Comparator group

Description:

Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.

Treatment:

Device: Hearing Aid without NR enabled

Hearing Aid with NR (1)

Experimental group

Description:

Hearing Aid with Noise Reduction I (NR) enabled.

Treatment:

Device: Hearing Aid with NR(1)

Hearing Aid with NR(2)

Experimental group

Description:

Hearing Aid with Noise Reduction II (NR) enabled.

Treatment:

Device: Hearing Aid with NR(2)

Hearing Aid with NR(3)

Experimental group

Description:

Hearing Aid with Noise Reduction III (NR) enabled.

Treatment:

Device: Hearing Aid with NR(3)