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Not yet recruitingNCT07580287Updated May 12, 2026

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

An interventional study of Bone conduction devices in Mixed Hearing Loss and Conductive Hearing Loss, sponsored by Oticon Medical. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Oticon Medical · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 84 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Mixed Hearing Loss
  • Conductive Hearing Loss

Keywords

  • Bone conduction hearing devices
  • conductive hearing loss
  • mixed hearing loss
  • bone conduction
03

In context

Hearing Loss, Mixed Conductive-Sensorineural

44 studies on the registry are indexed under Hearing Loss, Mixed Conductive-Sensorineural; 9 are open to participants now.

This study's planned enrollment of 20 is below the median of 25 across 33 interventional studies indexed under Hearing Loss, Mixed Conductive-Sensorineural.

Browse Hearing Loss, Mixed Conductive-Sensorineural studies →

Lead sponsor

Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed Form
  2. Adults (from 18 to 84 years)
  3. 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
  4. Fluent in Swedish to be able to read and understand patient information and informed consent process

Exclusion criteria

Exclusion Criteria:

  1. Participation in another clinical investigation which might cause interference with study participation.
  2. Participants who do not have the ability or are unwilling to follow procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Arm 1

    Device: Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D

    Other: Bone conduction devices

Interventions

  • OtherBone conduction devices

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline, at fitting

Secondary outcomes

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

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

    Time frame: Baseline, at fitting

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

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

    Time frame: Baseline, at fitting

07

Study locations

1 site
  • Chalmers
    Gothenburg, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07580287
Lead sponsor
Oticon Medical
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
May 12, 2026

Study contacts

Louise Waldenby
Contact
lowd@oticonmedical.com
+46735165389

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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