Pre-calculation for Frequency Lowering With Hearing Devices

Sonova

Status: Completed

Conditions: Frequency Lowering

Treatments: Other: Frequency lowering intervention; Other: Frequency lowering reference

Study type: Interventional

Funder types: Industry

Identifiers

NCT05733169

5937

Details and patient eligibility

About

Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Experienced hearing aid user (minimum use duration 1 year)
• Adult (minimum age: 18 years),
• Experience with frequency lowering,
• Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
• Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz) ,
• Sensorineural hearing loss,
• Air Conduction - bone conduction gap <= 10 dB,
• Written and spoken German,
• Ability to understand instruction,
• Ability to describe listening experiences,
• Ability to attend to the appointments,
• Ability to fill in a questionnaire conscientiously
• Healthy outer ear (without previous surgical procedures)
• 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),
• Not willing to wear the hearing aid,
• Fluctuating hearing that could influence the results,
• Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
• Limited mobility and not in the position to attend all appoint-ments,
• Limited ability to describe listening impressions/experiences and the use of the hearing aid,
• Inability to produce a reliable hearing test result,
• Massively limited dexterity,
• Known psychological problems,
• Known central hearing disorders.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Hearing impaired group

Experimental group

Description:

The hearing impaired group will compare the reference condition with the intervention condition.

Treatment:

Other: Frequency lowering reference

Other: Frequency lowering intervention