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Difficulty in recruitment
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| Name | Class |
|---|---|
| Med-El Corporation | INDUSTRY |
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The purpose of this research study is to learn about the hearing outcomes of adult and pediatric patients who are treated with or are candidates for bone conductive devices (also termed "BAHA"). Hearing outcomes will also be assessed with a second audio processor device called the Adhear System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Sided Deafness Adult (Aim1) Group | Experimental | Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). |
|
| Conductive Hearing Loss Adult (Aim 2) Group | Experimental | Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). |
|
| Adhear followed by BAHA (Aim 3) Group | Experimental | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 3 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 3 weeks (plus up to 90 days). |
|
| BAHA followed by Adhear (Aim 3) Group | Experimental | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 3 weeks (plus up to 90 days) followed by Adhear for another 3 weeks (plus up to 90 days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhear Bone Conduction System | Device | Non-invasive bone conduction hearing device using adhesive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aided Hearing Thresholds for Single Sided Deafness | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz. | Day 1 |
| Aided Hearing Thresholds for Conductive Hearing Loss | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz. | Day 1 |
| Aided Hearing Thresholds for Single Sided Deafness | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz. | Day 14 |
| Aided Hearing Thresholds for Conductive Hearing Loss | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz. | Day 14 |
| Aided Hearing Thresholds | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using a traditional bone conduction device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz. |
| Measure | Description | Time Frame |
|---|---|---|
| Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Aided speech-in-noise performance was measured in decibels. |
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Inclusion Criteria:
Aims 1 and 2:
Aim 3:
Aim 3 a & b:
Exclusion Criteria:
Aims 1 & 2:
Aim 3:
Aims 3a & 3b:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Snapp, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Department of Otolaryngology | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Sided Deafness Adult (Aim1) Group | Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| FG001 | Conductive Hearing Loss Adult (Aim 2) Group | Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| FG002 | Adhear Followed by BAHA (Aim 3) Group | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 2 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband |
| FG003 | BAHA Followed by Adhear (Aim 3) Group | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 2 weeks (plus up to 90 days) followed by Adhear for another 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband |
| FG004 | Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group | Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| FG005 | Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group | Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-Sided Deafness Adult (Aim1) Group | Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Aided Hearing Thresholds for Single Sided Deafness | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz. | This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | hertz | Day 1 |
|
506 days
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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 | Single-Sided Deafness Adult (Aim1) Group | Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hillary Snapp | University of Miami | 305-243-4611 | hsnapp@med.miami.edu |
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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 | Feb 28, 2023 | Apr 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Participants who are enrolled in Aims 3 are part of a cross-over design. Participants in this group will be randomly assigned to either standard of care followed by Adhear, or Adhear followed by standard of care.
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|
| Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group | Experimental | Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days). |
|
| Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group | Experimental | Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days). |
|
| Bone anchored hearing aid (BAHA) | Device | Non-invasive bone conduction hearing device using a headband |
|
| Day 14 of the intervention |
| Day 1 |
| Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Aided speech-in-noise performance was measured in decibels. | Day 1 |
| Aided Speech in Noise Performance in Participants With Single-sided Deafness | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Aided speech-in-noise performance was measured in decibels. | Day 14 |
| Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Aided speech-in-noise performance was measured in decibels. | Day 14 |
| Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire. | Day 1 |
| Participant Satisfaction With Adhear | Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire. | Day 14 |
| Participant Satisfaction With Adhear at Day 28 (Aim 3b) | Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire. | Day 28 |
| Lost to Follow-up |
|
| Screen Failure |
|
| BG001 | Conductive Hearing Loss Adult (Aim 2) Group | Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| BG002 | Adhear Followed by BAHA (Aim 3) Group | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 3 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 3 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband |
| BG003 | BAHA Followed by Adhear (Aim 3) Group | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 3 weeks (plus up to 90 days) followed by Adhear for another 3 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband |
| BG004 | Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group | Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| BG005 | Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group | Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Adhear Pre |
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear. |
|
|
| Primary | Aided Hearing Thresholds for Conductive Hearing Loss | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz. | This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | hertz | Day 1 |
|
|
|
| Primary | Aided Hearing Thresholds for Single Sided Deafness | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz. | This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | hertz | Day 14 |
|
|
|
| Primary | Aided Hearing Thresholds for Conductive Hearing Loss | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz. | This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | hertz | Day 14 |
|
|
|
| Primary | Aided Hearing Thresholds | Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using a traditional bone conduction device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz. | This outcome measure corresponds to Aim 3, Aim 3a, and Aim 3b. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. Insufficient sample collected for participants and thus the data could not be analyzed for arms BAHA Bilateral Conductive Hearing Loss Prior BAI Use and Adhear Bilateral Conducive Hearing Loss Prior BAI Use. | Posted | Mean | Standard Deviation | hertz | Day 14 of the intervention |
|
|
|
| Secondary | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Aided speech-in-noise performance was measured in decibels. | This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | dB | Day 1 |
|
|
|
| Secondary | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Aided speech-in-noise performance was measured in decibels. | This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | dB | Day 1 |
|
|
|
| Secondary | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Aided speech-in-noise performance was measured in decibels. | This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | dB | Day 14 |
|
|
|
| Secondary | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Aided speech-in-noise performance was measured in decibels. | This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | dB | Day 14 |
|
|
|
| Secondary | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire. | This outcome measure corresponds to Aims 1, 2, 3, 3a, and 3b. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| Secondary | Participant Satisfaction With Adhear | Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire. | This outcome measure corresponds to Aims 1, 2, 3, 3a, and 3b. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
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| Secondary | Participant Satisfaction With Adhear at Day 28 (Aim 3b) | Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire. | This outcome measure corresponds to Aim 3b.Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. | Posted | Mean | Standard Deviation | score on a scale | Day 28 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Conductive Hearing Loss Adult (Aim 2) Group | Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Adhear (Aim 3) Group | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss who have not previously used a bone conduction device, will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive | 0 | 33 | 0 | 33 | 0 | 33 |
| EG003 | BAHA (Aim 3) Group | Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss who have not previously used a bone conduction device, will be provided with the BAHA system for 2 weeks (plus up to 90 days). Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband | 0 | 33 | 0 | 33 | 0 | 33 |
| EG004 | Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group | Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive | 0 | 14 | 0 | 14 | 0 | 14 |
| EG005 | Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group | Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days). Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive | 0 | 4 | 0 | 4 | 0 | 4 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Frequency 1000 |
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| Frequency 2000 |
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| Frequency 3000 |
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| Frequency 4000 |
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| Frequency 6000 |
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| Frequency 8000 |
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| Frequency 1000 |
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| Frequency 2000 |
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| Frequency 3000 |
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| Frequency 4000 |
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| Frequency 6000 |
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| Frequency 8000 |
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| Frequency 1000 |
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| Frequency 2000 |
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| Frequency 3000 |
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| Frequency 4000 |
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| Frequency 6000 |
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| Frequency 8000 |
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| Frequency 500 |
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| Frequency 1000 |
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| Frequency 2000 |
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| Frequency 3000 |
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| Frequency 4000 |
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| Frequency 6000 |
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| Frequency 8000 |
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| Speech better ear / noise poorer ear |
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| Speech better ear / noise poorer ear |
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| Speech better ear/noise poorer ear |
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| Speech better ear/noise poorer ear |
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| Parent |
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| Parent |
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