Pre-calculation for Frequency Lowering With Hearing Devices

Not Applicable

Completed

• Conditions: Frequency Lowering
• Interventions: Other: Frequency lowering intervention; Other: Frequency lowering reference

• Registration Number: NCT05733169
• Lead Sponsor: Sonova AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-16
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hearing impaired group	Frequency lowering reference	The hearing impaired group will compare the reference condition with the intervention condition.
Hearing impaired group	Frequency lowering intervention	The hearing impaired group will compare the reference condition with the intervention condition.

Primary Outcome Measures

Name	Time	Method
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.	6 weeks

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Kanton Zürich, Switzerland