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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 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 |
|---|---|---|---|
| Sentio 1 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentio 1 | Device | Sound processor |
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| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Improvement of Hearing With the Sentio1 (PTA4) | Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4. The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Improvement of Hearing With the Sentio1 | Functional gain with Sentio 1, i.e., the difference in dB between unaided (without sound processor) and aided (with sound processor on) sound field thresholds, for all measured frequencies. In detail, for each patient, sound field thresholds are measured at the frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz, with and without the sound processor on. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Charlotte Persson | Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Habilitation & Health, Hearing organization | Gothenburg | 41663 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentio 1 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. Sentio 1: Sound processor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sentio 1 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. Sentio 1: Sound processor |
| Units | Counts |
|---|---|
| Participants |
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| 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 | To Assess the Improvement of Hearing With the Sentio1 (PTA4) | Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4. The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor). | Posted | Mean | Standard Deviation | dB | 1 month | Ears | Ears |
|
From enrollment up to 24 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 | Sentio 1 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. Sentio 1: Sound processor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Oticon Medical AB | 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 | Jul 4, 2023 | Mar 5, 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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| 1 month |
| Subjective Evaluation of Sound Processor Performance. | Sentio 1 compared to previous sound processor.
Measured by the Speech, Spatial and Quality (SSQ) scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". Higher scores mean a better outcome. For each of the scales the item outcomes are averaged. Fot the total score all items are averaged | 1 month |
| Subjective Sound Processor Preference | Percentage (%) of subjects who prefer the Sentio 1 over current sound processor | 1 month |
| To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss |
| 1 month |
| To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | Difference in dB between Sentio 1 BC in situ thresholds and BC thresholds measured with conventional unmasked BC audiometry for the frequencies 500, 1000, 2000, 3000 and 4000 Hz. The BC in-situ threshold is a measure of the inner ear functionality with the device. This should correspond to the unmasked BC thresholds measured with conventional audiometry. The difference was calculated as the threshold value measured with Sentio 1 minus the threshold value measured with conventional audiometry. Negative values indicate that the thresholds measured with Sentio 1 were lower (better) compared to those measured with conventional audiometry. Conversely, positive values indicate that the thresholds measured with Sentio 1 were higher (worse) compared to conventional audiometry. It's expected that two measurements should be comparable to each with a difference of maximum +/-5 dB. | 1 month |
| Assess Safety With the Sentio 1 Sound Processor | Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs. | 12 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
| Ears |
|
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| Secondary | To Assess the Improvement of Hearing With the Sentio1 | Functional gain with Sentio 1, i.e., the difference in dB between unaided (without sound processor) and aided (with sound processor on) sound field thresholds, for all measured frequencies. In detail, for each patient, sound field thresholds are measured at the frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz, with and without the sound processor on. | Posted | Mean | Standard Deviation | dB | 1 month | Ears | Ears |
|
|
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| Secondary | Subjective Evaluation of Sound Processor Performance. | Sentio 1 compared to previous sound processor.
Measured by the Speech, Spatial and Quality (SSQ) scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". Higher scores mean a better outcome. For each of the scales the item outcomes are averaged. Fot the total score all items are averaged | Posted | Mean | Standard Deviation | score on a scale | 1 month | Ears | Ears |
|
|
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| Secondary | Subjective Sound Processor Preference | Percentage (%) of subjects who prefer the Sentio 1 over current sound processor | Posted | Count of Participants | Participants | 1 month |
|
|
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| Secondary | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss |
| Posted | Mean | Standard Deviation | dB | 1 month |
|
|
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| Secondary | To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | Difference in dB between Sentio 1 BC in situ thresholds and BC thresholds measured with conventional unmasked BC audiometry for the frequencies 500, 1000, 2000, 3000 and 4000 Hz. The BC in-situ threshold is a measure of the inner ear functionality with the device. This should correspond to the unmasked BC thresholds measured with conventional audiometry. The difference was calculated as the threshold value measured with Sentio 1 minus the threshold value measured with conventional audiometry. Negative values indicate that the thresholds measured with Sentio 1 were lower (better) compared to those measured with conventional audiometry. Conversely, positive values indicate that the thresholds measured with Sentio 1 were higher (worse) compared to conventional audiometry. It's expected that two measurements should be comparable to each with a difference of maximum +/-5 dB. | Posted | Mean | Standard Error | dB | 1 month | Ears | Ears |
|
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| Secondary | Assess Safety With the Sentio 1 Sound Processor | Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs. | Not Posted | 12 months | Participants |
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| 11 |
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| 11 |
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| 11 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| 2000Hz |
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| 3000Hz |
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| 4000Hz |
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| 6000Hz |
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| 8000Hz |
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| SSQ Quality |
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| SSQ Total |
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| Title | Measurements |
|---|
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| 3000Hz |
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| 4000Hz |
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| PTA4 |
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| Title | Measurements |
|---|---|
|
| 3000Hz |
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| 4000Hz |
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