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NCT Number: NCT07580287

Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction

This study will investigate the performance of four non-surgical bone conduction devices.

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Key information

Conditions

Mixed Hearing Loss Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed Informed Consent Form
  • Adults (from 18 to 84 years)
  • Pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) less than 25 dB HL on both ears
  • Fluent in Swedish to be able to read and understand patient information and informed consent process

Exclusion criteria

  • Participation in another clinical investigation which might cause interference with study participation.
  • Participants who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.

Treatment and study plan

Bone conduction devices

Other

Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D

Primary outcomes

  1. Difference in aided thresholds between device A and device B for PTA4.

    Time frame: Baseline, at fitting

    PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.

Secondary outcomes

  1. Difference in aided thresholds between device A and device C for PTA4.

    Time frame: Baseline, at fitting

    PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.

  2. Difference in aided thresholds between device A and device D for PTA4.

    Time frame: Baseline, at fitting

    PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.

Study contacts

Contact information is provided by the study sponsor or research team.

Louise Waldenby

CONTACT

[email protected]

+46735165389

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

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.

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