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OpenTrials
Completed

NCT Number: NCT05733169

Pre-calculation for Frequency Lowering With Hearing Devices

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

Completed

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Key information

Conditions

Frequency Lowering

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frequency lowering intervention

Other

Modified parametrization of the current frequency lowering parametrization.

Other names: Intervention condition

Frequency lowering reference

Other

Current frequency lowering parametrization

Other names: Reference condition

Primary outcomes

  1. 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.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.