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Not yet recruiting NCT07580287

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

No phase Interventional Mixed Hearing Loss Conductive Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bone conduction devices.
Who it may be relevant to
Registry conditions: Mixed Hearing Loss, Conductive Hearing Loss. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other Bone conduction devices
    Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D

Primary outcome measures

  • Difference in aided thresholds between device A and device B for PTA4. [Time frame: Baseline, at fitting]
Secondary outcome measures (2)
  • Difference in aided thresholds between device A and device C for PTA4. [Time frame: Baseline, at fitting]
  • Difference in aided thresholds between device A and device D for PTA4. [Time frame: Baseline, at fitting]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

Sweden · 1 center
  • Chalmers — Gothenburg

Identifiers

NCT: NCT07580287 · BC124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗