Conductive Hearing Loss, Mixed Hearing Loss
Conditions
Brief 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.
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.
Interventions
DEVICEFusion Sound Processor
Sound Processor
Sponsors
Sahlgrenska University Hospital
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Inability to participate in follow-ups * Unsuitable as judged by the principle investigator or the sub-investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aided Thresholds Fusion-unaided PTA | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aided Thresholds Fusion PTA4 | Baseline, 1 and 6 month(s) | Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) |
| Aided Thresholds Fusion | Baseline, 1 and 6 month(s) | Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at |
| Aided Thresholds Fusion-BCI PTA4 | 6 months | Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4) |
| Aided Thresholds Fusion-BCI | 6 months | 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 |
| Speech Intelligibility Fusion-unaided % | 6 months | 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. |
| Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR) | 6 months | 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. |
| Speech Intelligibility Fusion % | Baseline, 1 and 6 month(s) | 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. |
| Aided Thresholds Fusion-unaided | 6 months | 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 |
| Speech Intelligibility Fusion-BCI % | 6 months | 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 |
| Speech Intelligibility Fusion-BCI SNR | 6 months | 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. |
| Magnet Strength | Baseline, 1 and 6 month(s) | Difference in magnet strength measured on the patient's heads in Newton |
| IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation | Baseline, 1 and 6 month(s) | 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 |
| Subjective Evaluation | Baseline, 1 and 6 month(s) | 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. |
| Subjective Evaluation SSQ | Baseline, 1 and 6 month(s) | 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. |
| Speech Intelligibility Fusion SNR | Baseline, 1 and 6 month(s) | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fusion Sound Processor The group is fitted with a Fusion Sound Processor. 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Fusion Sound Processor | — |
|---|---|---|
| Age, Continuous | 46.7 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 10 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fusion Sound Processor | Aided Thresholds Fusion-unaided PTA | 29.6 dB | Standard Deviation 4.4 |
Secondary
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)
Secondary
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
Secondary
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
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fusion Sound Processor | Aided Thresholds Fusion PTA4 | Difference between 0-1 months | -0.290 dB | Standard Deviation 1.386 |
| Fusion Sound Processor | Aided Thresholds Fusion PTA4 | Difference between 0-6 months | -1.07 dB | Standard Deviation 2.93 |
| Fusion Sound Processor | Aided Thresholds Fusion PTA4 | Difference between 1-6 months | -0.78 dB | Standard Deviation 2.754 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 8000 | 17.5 dB | Standard Deviation 10.1 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 2000 | 27.5 dB | Standard Deviation 8.2 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 3000 | 25.0 dB | Standard Deviation 8.2 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 4000 | 26.5 dB | Standard Deviation 7.8 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 6000 | 22.5 dB | Standard Deviation 8.6 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 250 | 10.05 dB | Standard Deviation 5.5 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 500 | 26.5 dB | Standard Deviation 7.5 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 750 | 36.5 dB | Standard Deviation 5.3 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 1000 | 38.0 dB | Standard Deviation 7.9 |
| Fusion Sound Processor | Aided Thresholds Fusion-unaided | 1500 | 28.5 dB | Standard Deviation 6.7 |
Secondary
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)
Secondary
Magnet Strength
Difference in magnet strength measured on the patient's heads in Newton
Time frame: Baseline, 1 and 6 month(s)
Secondary
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)
Secondary
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
Secondary
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
Secondary
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)
Secondary
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
Secondary
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
Secondary
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)
Secondary
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)