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| Name | Class |
|---|---|
| Statistiska Konsultgruppen | OTHER |
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The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New SP followed by Baha 5 SP followed by single blinded SP | Experimental | Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing). |
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| Baha 5 SP followed by the New SP followed by single blinded SP | Experimental | Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Sound Processor | Device | The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss. |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding | Day 0, day 7 and day 14 |
| Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor. | Day 7 and day 14 |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Ganlöv, MD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Bone Anchored Solutions AB (CBAS) | Mölnlycke | SE-435 33 | Sweden |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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16 participants were recruited in one centre from 23 September 2020 to 27 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baha 6 Max Followed by Baha 5 SP Followed by Unaided Hearing | Participants received Baha 6 Max followed by Baha 5 SP followed by Unaided |
| FG001 | Baha 5 SP Followed by Baha 6 Max Followed by Unaided Hearing | Participants received Baha 5 SP followed by Baha 6 Max followed by Unaided |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (Day 0) |
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| Intervention 2 (Day 7) |
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| Intervention 3 (Day 14) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Crossover, participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided |
| 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, Categorical | Count of Participants |
| 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 | Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding | Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants. | Posted | Mean | Standard Deviation | db SNR (decibel Speech in Noise Ratio) | Day 0, day 7 and day 14 |
|
14 days
Participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided
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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 | Baha 6 Max | Baha 6 Max SP | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therese Agat | Cochlear | +46766498562 | tagat@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2020 | Sep 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2021 | Sep 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding |
| Day 0 and day 7 |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz] | Day 0 and day 7 |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words. | Day 0 and day 7 |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips. | Day 14 |
| Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Participant rating Yes or No for internal noise after listening to sound clips. | Day 14 |
| Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. | Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort. | Day 14 |
| Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz] | Day 0, day 7 and day 14 |
| Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words | Day 0, day 7 and day 14 |
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| NOT COMPLETED |
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| Participants |
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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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| Region of Enrollment | Count of Participants | Participants |
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Unaided hearing
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| Primary | Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF | Participants received Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7 | Posted | Count of Participants | Participants | Day 14 |
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| Secondary | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor. | 16 participants assessed Baha 6 Max or Baha 5 SP at day 7 followed by Baha 5 SP or Baha 6 Max at day 14 | Posted | Count of Participants | Participants | Day 7 and day 14 |
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| Secondary | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding | 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7 | Posted | Mean | Standard Deviation | dB SNR | Day 0 and day 7 |
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| Secondary | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz] | 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7 | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Day 0 and day 7 |
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|
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| Secondary | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words. | 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7 | Posted | Mean | Standard Deviation | Percentage of correct words | Day 0 and day 7 |
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| Secondary | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips. | No data for speech understanding on sound clip 2 and for sound clarity on sound clip 1. | Posted | Mean | Standard Deviation | Score on a scale | Day 14 |
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| Secondary | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Participant rating Yes or No for internal noise after listening to sound clips. | Posted | Count of Participants | Participants | Day 14 |
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| Secondary | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. | Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort. | Data are for sound clip 1. No data available for sound clip 2. | Posted | Mean | Standard Deviation | Score on a scale | Day 14 |
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| Secondary | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz] | Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Day 0, day 7 and day 14 |
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| Secondary | Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words | Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants. | Posted | Mean | Standard Deviation | Percentage of correct words | Day 0, day 7 and day 14 |
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| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Baha 5 | Baha 5 SP | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Unaided | Unaided hearing | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Daily use > 16 hours |
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| Change battery in device |
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| No change battery in device |
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| Change to their own SP |
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| No change to their own SP |
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| 1000 Hz |
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| 2000 Hz |
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| 3000 Hz |
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| 4000 Hz |
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| 6000 Hz |
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| 8000 Hz |
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| 9000 Hz |
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| 10000 Hz |
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| Artefacts- sound clip 1 |
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| Artefacts- sound clip 2 |
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| Speech understanding- sound clip 1 |
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| Sound quality- sound clip 1 |
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| Sound quality- sound clip 2 |
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| Sound clarity-sound clip 2 |
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| Sound clip 2-Yes |
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| Sound clip 2-No |
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| 1000 Hz |
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| 2000 Hz |
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| 3000 Hz |
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| 4000 Hz |
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| 6000 Hz |
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| 8000 Hz |
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| 9000 Hz |
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| 10000 Hz |
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