An interventional study of Fusion Sound Processor in Conductive Hearing Loss and Mixed Hearing Loss, sponsored by Oticon Medical. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Oticon Medical · Not applicable, Interventional, and Device feasibility
Among 19 studies in Hearing Loss, Conductive by Oticon Medical — 2 open to participants now, 4 under way, none of them phase 3. Hearing Loss, Conductive · Oticon Medical.
Among the 19 studies in Hearing Loss, Conductive by Oticon Medical, this one is the 13th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2017, is one of 13 with no phase, and was the 8th registered.
82 studies on the registry are indexed under Hearing Loss, Conductive; 15 are open to participants now.
Browse Hearing Loss, Conductive studies →2 of the 19 studies in Hearing Loss, Conductive by Oticon Medical are open now, in 1 country. Recruiting first, the newest first:
Oticon Medical · Sites in Sweden
Oticon Medical
By country, each count listing its studies:
Of the 9 Hearing Loss, Conductive studies recruiting now, 5 (56%) set no upper age limit and 1 (11%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2017.
This study's enrollment of 10 is below the median of 30 across 59 interventional studies indexed under Hearing Loss, Conductive.
Median enrollment 30 across the 13 interventional studies, 41 across the 6 observational. Of the 15 that completed or were terminated, 6 (40%) have results posted.
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Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 19 studies in Hearing Loss, Conductive by Oticon Medical, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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.
Exclusion Criteria:
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.
Device: Fusion Sound Processor
Sound Processor
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)
Time frame: 6 months
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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6 months
Magnet Strength
Difference in magnet strength measured on the patient's heads in Newton
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 and 6 month(s)
| Milestone | Fusion Sound Processor |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
| dB | Fusion Sound Processor |
|---|---|
| Aided Thresholds Fusion-unaided PTA | 29.6 ± 4.4 |
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
| dB | Fusion Sound Processor |
|---|---|
| 250 | 10.05 ± 5.5 |
| 500 | 26.5 ± 7.5 |
| 750 | 36.5 ± 5.3 |
| 1000 | 38.0 ± 7.9 |
| 1500 | 28.5 ± 6.7 |
| 2000 | 27.5 ± 8.2 |
| 3000 | 25.0 ± 8.2 |
| 4000 | 26.5 ± 7.8 |
| 6000 | 22.5 ± 8.6 |
| 8000 | 17.5 ± 10.1 |
Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
| dB | Fusion Sound Processor |
|---|---|
| Difference between 0-1 months | -0.290 ± 1.386 |
| Difference between 0-6 months | -1.07 ± 2.93 |
| Difference between 1-6 months | -0.78 ± 2.754 |
Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at
Results for this outcome have not been posted.
Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Difference in magnet strength measured on the patient's heads in Newton
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fusion Sound Processor | 0/10 (0%) | 0/10 (0%) | 7/10 (70%) |
| Event | Fusion Sound Processor |
|---|---|
| NasopharyngitisInfections and infestations | 2/10 |
| Implant site painGeneral disorders | 1/10 |
| Implat site paraesthesiaGeneral disorders | 1/10 |
| Medical device site irritationGeneral disorders | 1/10 |
| PyrexiaGeneral disorders | 1/10 |
| Seasonal allergyImmune system disorders | 1/10 |
| Ear infectionInfections and infestations | 1/10 |
| Ankle fractureInjury, poisoning and procedural complications | 1/10 |
| Arthropod biteInjury, poisoning and procedural complications | 1/10 |
| Ligament ruptureInjury, poisoning and procedural complications | 1/10 |
| Age, Continuous(years) | Fusion Sound Processor |
|---|---|
| Median | 46.7 (22 to 71) |
| Sex: Female, Male(Participants) | Fusion Sound Processor |
|---|---|
| Female | 6 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | Fusion Sound Processor |
|---|
| Region of Enrollment(participants) | Fusion Sound Processor |
|---|---|
| Sweden | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Nov 2018, 12 months.
Results were first posted in Dec 2024, 6 years after primary completion.
Of 37 interventional studies with no phase under Hearing Loss, Conductive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 25. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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