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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fusion Sound Processor | Device | Sound Processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Aided Thresholds Fusion PTA4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Måns Eeg Olofsson, MD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT departement, Sahlgrenska University Hospital | Gothenburg | 413 46 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | dB | 6 months |
|
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Oticon Medical | 0046-31-7486100 | studyinfo@oticonmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2018 | Mar 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
| 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 | 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) | 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 | 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. | 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. | 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. | 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. | 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 | 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. | 6 months |
| Magnet Strength | Difference in magnet strength measured on the patient's heads in Newton | 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 | 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. | 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. | Baseline, 1 and 6 month(s) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Mean | Standard Deviation | dB | 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) | Posted | Mean | Standard Deviation | dB | Baseline, 1 and 6 month(s) |
|
|
|
| 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 | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 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) | Not Posted | 6 months | Participants |
| 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 | Not Posted | 6 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| 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. | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 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. | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 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 | Not Posted | 6 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| Secondary | Magnet Strength | Difference in magnet strength measured on the patient's heads in Newton | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 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 | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 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. | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 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. | Not Posted | Baseline, 1 and 6 month(s) | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| Implat site paraesthesia | General disorders | Systematic Assessment |
|
| Medical device site irritation | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 8000 |
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