Conductive Hearing LossNCT03374787
Evaluation of Sound Processor for a Transcutaneous System
A study testing Fusion Sound Processor in people with Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 1 site in Sweden.
Trial summary
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Conductive Hearing Loss, Mixed Hearing Loss
- What is being tested?
- Fusion Sound Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2017to 22 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects implanted with the Bridging Bone Conductor (BBC) implant
- Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
- Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
- Active user of the BCI SP
Who cannot join
- Inability to participate in follow-ups
- Unsuitable as judged by the principle investigator or the sub-investigator
Trial locations and contacts
1 site in 1 country.
Sweden1 site
ENT departement, Sahlgrenska University Hospital
Gothenburg, 413 46
About this study
Official title: Single Center Evaluation of a Sound Processor for a Transcutaneous System
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.
Read the detailed description
Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss
- Being tested
- Fusion Sound Processor
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusion Sound ProcessorDevice
Sound Processor
| Study group | Role | What they receive |
|---|---|---|
| Fusion sound processor | Experimental | The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear. Receives: Device: Fusion Sound Processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aided Thresholds Fusion-unaided PTA
Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
Measured: 6 months
Secondary outcomes (15)
Aided Thresholds Fusion-unaided
Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz
Measured: 6 months
Aided Thresholds Fusion PTA4
Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
Measured: Baseline, 1 and 6 month(s)
Aided Thresholds Fusion
Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at
Measured: Baseline, 1 and 6 month(s)
Aided Thresholds Fusion-BCI PTA4
Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)
Measured: 6 months
Aided Thresholds Fusion-BCI
Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz
Measured: 6 months
Speech Intelligibility Fusion-unaided %
Difference between Fusion-aided and unaided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.
Measured: 6 months
Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR)
Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.
Measured: 6 months
Speech Intelligibility Fusion %
Difference between Fusion-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.
Measured: Baseline, 1 and 6 month(s)
Speech Intelligibility Fusion SNR
Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.
Measured: Baseline, 1 and 6 month(s)
Speech Intelligibility Fusion-BCI %
Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used
Measured: 6 months
Speech Intelligibility Fusion-BCI SNR
Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.
Measured: 6 months
Magnet Strength
Difference in magnet strength measured on the patient's heads in Newton
Measured: Baseline, 1 and 6 month(s)
IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation
Combined score of IInflammation, Pain and Skin height/numbness scale evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales). Lower score means better performance
Measured: Baseline, 1 and 6 month(s)
Subjective Evaluation
User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor. The scale used is a scale with descriptive values.
Measured: Baseline, 1 and 6 month(s)
Subjective Evaluation SSQ
Subjective performance as measured by Speech, Spatial and Qualities of hearing (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". A higher score means better performance.
Measured: Baseline, 1 and 6 month(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start15 Nov 2017
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Måns Eeg Olofsson, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374787
- Sponsor's protocol ID
- C58
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2017
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Evaluation of a Sound Processor for a Transcutaneous System
- ClinicalTrials.gov ID
- NCT03374787
- Acronym / sponsor ID
- C58
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.
Detailed description
Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fusion sound processor | Experimental | Device: Fusion Sound ProcessorThe sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects implanted with the Bridging Bone Conductor (BBC) implant
- Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
- Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
- Active user of the BCI SP
Key exclusion criteria (2 listed)
- Inability to participate in follow-ups
- Unsuitable as judged by the principle investigator or the sub-investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fusion Sound ProcessorSound Processor | Device | Fusion sound processor |
Primary outcome
Aided Thresholds Fusion-unaided PTA
Time frame: 6 months
Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
15 secondary outcomes
Aided Thresholds Fusion-unaided
Time frame: 6 months
Aided Thresholds Fusion PTA4
Time frame: Baseline, 1 and 6 month(s)
Aided Thresholds Fusion
Time frame: Baseline, 1 and 6 month(s)
Aided Thresholds Fusion-BCI PTA4
Time frame: 6 months
Aided Thresholds Fusion-BCI
Time frame: 6 months
Speech Intelligibility Fusion-unaided %
Time frame: 6 months
Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR)
Time frame: 6 months
Speech Intelligibility Fusion %
Time frame: Baseline, 1 and 6 month(s)
Speech Intelligibility Fusion SNR
Time frame: Baseline, 1 and 6 month(s)
Speech Intelligibility Fusion-BCI %
Time frame: 6 months
Speech Intelligibility Fusion-BCI SNR
Time frame: 6 months
Magnet Strength
Time frame: Baseline, 1 and 6 month(s)
IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation
Time frame: Baseline, 1 and 6 month(s)
Subjective Evaluation
Time frame: Baseline, 1 and 6 month(s)
Subjective Evaluation SSQ
Time frame: Baseline, 1 and 6 month(s)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Måns Eeg Olofsson, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fusion Sound Processor in people with Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aided Thresholds Fusion-unaided PTA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.