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 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
DEVICESentio 1
Sound processor
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent Form 2. Adult subjects (18 years or older) 3. Subjects implanted with an I1 implant 4. Fluent in Swedish
Exclusion criteria
1. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion. 2. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Improvement of Hearing With the Sentio1 (PTA4) | 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Evaluation of Sound Processor Performance. | 1 month | Sentio 1 compared to previous sound processor. 1. Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total. 2. Average SSQ12 scores with current sound processor for each question, sub-scales and in total. 3. Difference in SSQ12 scores between Sentio 1 and current sound processor for each question, sub-scales and in total. 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 |
| Subjective Sound Processor Preference | 1 month | Percentage (%) of subjects who prefer the Sentio 1 over current sound processor |
| To Assess the Improvement of Hearing With the Sentio1 | 1 month | 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. |
| To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | 1 month | 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. |
| Assess Safety With the Sentio 1 Sound Processor | 12 months | Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs. |
| To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | 1 month | 1. Effective gain defined as the difference in dB between aided sound field thresholds with Sentio 1 and unmasked BC thresholds on the aided ear(s). The effective gain is calculated for all measured frequencies. 2. Effective gain with Sentio 1, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Sentio 1 Sound Processor | — |
|---|---|---|
| Age, Continuous | 51 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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).
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 (PTA4) | 32.5 dB | Standard Deviation 6.8 |
Secondary
Assess Safety With the Sentio 1 Sound Processor
Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.
Time frame: 12 months
Secondary
Subjective Evaluation of Sound Processor Performance.
Sentio 1 compared to previous sound processor. 1. Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total. 2. Average SSQ12 scores with current sound processor for each question, sub-scales and in total. 3. Difference in SSQ12 scores between Sentio 1 and current sound processor for each question, sub-scales and in total. 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
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Functional Gain PTA4 (Sentio 1 Sound Processor) | Subjective Evaluation of Sound Processor Performance. | SSQ Speech | 5.58 score on a scale | Standard Deviation 2.32 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | Subjective Evaluation of Sound Processor Performance. | SSQ Spatial | 4.34 score on a scale | Standard Deviation 3.02 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | Subjective Evaluation of Sound Processor Performance. | SSQ Quality | 6.21 score on a scale | Standard Deviation 2.12 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | Subjective Evaluation of Sound Processor Performance. | SSQ Total | 5.47 score on a scale | Standard Deviation 2.18 |
| Sentio 1 Sound Processor | Subjective Evaluation of Sound Processor Performance. | SSQ Total | 5.78 score on a scale | Standard Deviation 2.26 |
| Sentio 1 Sound Processor | Subjective Evaluation of Sound Processor Performance. | SSQ Speech | 6.07 score on a scale | Standard Deviation 2.67 |
| Sentio 1 Sound Processor | Subjective Evaluation of Sound Processor Performance. | SSQ Quality | 6.22 score on a scale | Standard Deviation 1.7 |
| Sentio 1 Sound Processor | Subjective Evaluation of Sound Processor Performance. | SSQ Spatial | 4.68 score on a scale | Standard Deviation 2.9 |
| Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) | Subjective Evaluation of Sound Processor Performance. | SSQ Total | 0.402 score on a scale | Standard Deviation 0.937 |
| Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) | Subjective Evaluation of Sound Processor Performance. | SSQ Spatial | 0.353 score on a scale | Standard Deviation 1.59 |
| Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) | Subjective Evaluation of Sound Processor Performance. | SSQ Quality | 0.154 score on a scale | Standard Deviation 0.92 |
| Difference Between Visit 2 (Sentio 1) and Visit 1 (Previous Device) | Subjective Evaluation of Sound Processor Performance. | SSQ Speech | 0.579 score on a scale | Standard Deviation 1.537 |
Secondary
Subjective Sound Processor Preference
Percentage (%) of subjects who prefer the Sentio 1 over current sound processor
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Functional Gain PTA4 (Sentio 1 Sound Processor) | Subjective Sound Processor Preference | 7 Participants |
Secondary
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss
1. Effective gain defined as the difference in dB between aided sound field thresholds with Sentio 1 and unmasked BC thresholds on the aided ear(s). The effective gain is calculated for all measured frequencies. 2. Effective gain with Sentio 1, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | 500Hz | 20.5 dB | Standard Deviation 13.6 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | 1000Hz | 11.0 dB | Standard Deviation 7.4 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | 2000Hz | 1.50 dB | Standard Deviation 10.01 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | 3000Hz | 12.5 dB | Standard Deviation 9.2 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | 4000Hz | 14.5 dB | Standard Deviation 9 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss | PTA4 | 11.9 dB | Standard Deviation 7.7 |
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.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | 500Hz | -4.7 dB | Standard Error 11.5 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | 1000Hz | -3.4 dB | Standard Error 9 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | 2000Hz | -6.7 dB | Standard Error 7.9 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | 3000Hz | 8.2 dB | Standard Error 8.4 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. | 4000Hz | 9.9 dB | Standard Error 9.2 |
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.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 250Hz | 18.5 dB | Standard Deviation 11.6 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 500Hz | 29.5 dB | Standard Deviation 12.1 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 1000Hz | 35.0 dB | Standard Deviation 6.2 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 2000Hz | 33.5 dB | Standard Deviation 10.3 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 3000Hz | 35.0 dB | Standard Deviation 13.1 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 4000Hz | 32.0 dB | Standard Deviation 8.9 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 6000Hz | 23.5 dB | Standard Deviation 9.1 |
| Functional Gain PTA4 (Sentio 1 Sound Processor) | To Assess the Improvement of Hearing With the Sentio1 | 8000Hz | 17.8 dB | Standard Deviation 12.9 |