Hearing Loss, ConductiveNCT03533686

Adhear Bone Conduction System

A study testing Adhear Bone Conduction System and Bone anchored hearing aid (BAHA) in people with Hearing Loss, Conductive and Hearing Loss, Unilateral, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Hearing Loss, Conductive, Hearing Loss, Unilateral
What is being tested?: Adhear Bone Conduction System and Bone anchored hearing aid (BAHA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 26 Apr 2018to 18 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Aims 1 and 2:
Adult English speaking patients who are experienced users of Bone Anchored Implants (BAIs) for the indication of either single sided deafness or conductive hearing loss.
Experienced will be defined as greater than 6 months of device use and no intermittent function of the device within 2 weeks of enrollment.
Subjects will be limited to those who have normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, \& 3000 Hz in at least one ear.
Aim 3:
English speaking children 5 to 17 years of age and their primary guardian who present to the clinic for treatment by BAI on a headband device for the indications of single sided deafness or conductive hearing loss.

Show all 10Show fewer

Subjects will be limited to those who have no prior use of a BAI or bone conduction hearing device, normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, \& 3000 Hz in at least one ear. For those children where this cannot be definitively established, children will be included who display clinical signs of normal bone conduction hearing beyond a reasonable doubt and may include such evidence as (but not limited to): auditory brainstem response, speech awareness thresholds, visual reinforcement audiometry, conditioning play audiometry, CT scans, etc.)
Aim 3 a \& b:
Pediatric bilateral or unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age
Pediatric participants who are currently managed by the University of Miami with a bone conduction device attached to a softband.

Who cannot join

Aims 1 \& 2:
Non-English speakers
Participants reporting allergies to adhesives or highly reactive skin.
Aim 3:
Pediatric participants who are non-English speakers.
Children who have previous experience with a BAI or bone conduction hearing device will not be included for study.

Show all 10Show fewer

Pediatric participants reporting allergies to adhesives or highly reactive skin.
Aims 3a \& 3b:
Pediatric participants who are non-English speakers.
Pediatric participants reporting allergies to adhesives or highly reactive skin.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami Department of Otolaryngology
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices

Conditions: Hearing Loss, Conductive, Hearing Loss, Unilateral
Being tested: Adhear Bone Conduction System, Bone anchored hearing aid (BAHA)
Medical subject headings: Hearing Loss, Conductive, Hearing Loss, Unilateral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adhear Bone Conduction SystemDevice
Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA)Device
Non-invasive bone conduction hearing device using a headband

Study groups in NCT03533686
Study group	Role	What they receive
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). Receives: Device: Adhear Bone Conduction System
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). Receives: Device: Adhear Bone Conduction System
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). Receives: Device: Adhear Bone Conduction System; Device: Bone anchored hearing aid (BAHA)
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). Receives: Device: Adhear Bone Conduction System; Device: Bone anchored hearing aid (BAHA)
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). Receives: Device: Adhear Bone Conduction System
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). Receives: Device: Adhear Bone Conduction System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14 of the intervention

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 201818 Mar 2022

First posted23 May 2018
Study start26 Apr 2018
Primary completion18 Mar 2022
Study completion18 Mar 2022

Why it stopped: Difficulty in recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03533686
Sponsor's protocol ID: 20161220
Status last verified: Jul 2023
First submitted: 30 Apr 2018
Last updated: 8 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Recruiting
Evaluation of Flexible Conductive Hearing Aids
Conductive Hearing Loss
RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Bone Conduction, Hearing Loss, Conductive
Active, not recruiting
Expanded Indications in the Pediatric BONEBRIDGE Population
Hearing Loss, Conductive, Hearing Loss, Mixed

All Hearing Loss, Conductive trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices
ClinicalTrials.gov ID: NCT03533686
Acronym / sponsor ID: 20161220
Conditions: Hearing Loss, Conductive, Hearing Loss, Unilateral
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty in recruitment
Enrolment: 66 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Med-El Corporation
Study start: 26 Apr 2018 (actual)
Primary completion: 18 Mar 2022 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 23 May 2018 (actual)
Results: Posted 8 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: 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.

Arm	Type	Receives
Single-Sided Deafness Adult (Aim1) Group	Experimental	Device: Adhear Bone Conduction SystemAdult 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	Device: Adhear Bone Conduction SystemAdult 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	Device: Adhear Bone Conduction System, Device: Bone anchored hearing aid (BAHA)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	Device: Adhear Bone Conduction System, Device: Bone anchored hearing aid (BAHA)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).
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group	Experimental	Device: Adhear Bone Conduction SystemPediatric 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	Device: Adhear Bone Conduction SystemPediatric 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).

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

Adult English speaking patients who are experienced users of Bone Anchored Implants (BAIs) for the indication of either single sided deafness or conductive hearing loss.
Experienced will be defined as greater than 6 months of device use and no intermittent function of the device within 2 weeks of enrollment.
Subjects will be limited to those who have normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, \& 3000 Hz in at least one ear.
English speaking children 5 to 17 years of age and their primary guardian who present to the clinic for treatment by BAI on a headband device for the indications of single sided deafness or conductive hearing loss.
Subjects will be limited to those who have no prior use of a BAI or bone conduction hearing device, normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, \& 3000 Hz in at least one ear. For those children where this cannot be definitively established, children will be included who display clinical signs of normal bone conduction hearing beyond a reasonable doubt and may include such evidence as (but not limited to): auditory brainstem response, speech awareness thresholds, visual reinforcement audiometry, conditioning play audiometry, CT scans, etc.)

Key exclusion criteria (10 listed)

Non-English speakers
Participants reporting allergies to adhesives or highly reactive skin.
Pediatric participants who are non-English speakers.
Children who have previous experience with a BAI or bone conduction hearing device will not be included for study.
Pediatric participants reporting allergies to adhesives or highly reactive skin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adhear Bone Conduction SystemNon-invasive bone conduction hearing device using adhesive	Device	Adhear followed by BAHA (Aim 3) Group, BAHA followed by Adhear (Aim 3) Group, Conductive Hearing Loss Adult (Aim 2) Group, Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group, Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group, Single-Sided Deafness Adult (Aim1) Group
Bone anchored hearing aid (BAHA)Non-invasive bone conduction hearing device using a headband	Device	Adhear followed by BAHA (Aim 3) Group, BAHA followed by Adhear (Aim 3) Group

Primary outcome

Aided Hearing Thresholds for Single Sided Deafness
Time frame: Day 1
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.
Aided Hearing Thresholds for Conductive Hearing Loss
Time frame: Day 1
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.
Aided Hearing Thresholds for Single Sided Deafness
Time frame: Day 14
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.
Aided Hearing Thresholds for Conductive Hearing Loss
Time frame: Day 14
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.
Aided Hearing Thresholds
Time frame: Day 14 of the intervention
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.

7 secondary outcomes

Aided Speech-in-noise Performance in Participants With Single-sided Deafness
Time frame: Day 1
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Time frame: Day 1
Aided Speech in Noise Performance in Participants With Single-sided Deafness
Time frame: Day 14
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Time frame: Day 14
Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
Time frame: Day 1
Participant Satisfaction With Adhear
Time frame: Day 14
Participant Satisfaction With Adhear at Day 28 (Aim 3b)
Time frame: Day 28

Results and safety

Results posted to the registry on 8 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-Sided Deafness Adult (Aim1) Group	9	8
Conductive Hearing Loss Adult (Aim 2) Group	3	2
Adhear Followed by BAHA (Aim 3) Group	18	18
BAHA Followed by Adhear (Aim 3) Group	15	10
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group	17	10
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group	4	3

Primary outcome: Aided Hearing Thresholds for Single Sided Deafness

Time frame: Day 1. Mean (Standard Deviation). Unit: hertz

Measure	BAHA Implant n = 8	Adhear Pre n = 8
Frequency 250	36.25 (7.44)	35.63 (10.16)
Frequency 500	28.13 (6.51)	37.50 (7.07)
Frequency 1000	20 (2.67)	30.63 (6.23)
Frequency 2000	23.13 (2.59)	35.00 (8.45)
Frequency 3000	27.5 (5.35)	44.38 (4.17)
Frequency 4000	33.13 (5.94)	51.25 (6.94)
Frequency 6000	31.88 (6.51)	56.88 (5.30)
Frequency 8000	40 (11.65)	56.88 (7.53)

Population analysed: 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.

Primary outcome: Aided Hearing Thresholds for Conductive Hearing Loss

Time frame: Day 1. Mean (Standard Deviation). Unit: hertz

Measure	BAHA Implant n = 3	Adhear Pre n = 3
Frequency 250	17.5 (3.54)	27.5 (3.54)
Frequency 500	12.5 (10.61)	20 (0)
Frequency 1000	22.50 (3.54)	22.5 (3.54)
Frequency 2000	27.5 (3.54)	30 (7.07)
Frequency 3000	35 (0)	40 (7.07)
Frequency 4000	37.5 (10.61)	55 (7.07)
Frequency 6000	40 (14.14)	50 (7.07)
Frequency 8000	47.5 (3.54)	55 (7.07)

Population analysed: 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.

Primary outcome: Aided Hearing Thresholds for Single Sided Deafness

Time frame: Day 14. Mean (Standard Deviation). Unit: hertz

Measure	Baha Softband n = 8	Adhear Post n = 8
Frequency 250	37.5 (6.78)	31.88 (11.27)
Frequency 500	31.75 (9.11)	32.13 (9.63)
Frequency 1000	24.38 (7.01)	28.38 (4.98)
Frequency 2000	28.88 (6.60)	31.75 (7.40)
Frequency 3000	35.38 (6.91)	42.88 (4.82)
Frequency 4000	45.25 (6.36)	50.75 (7.80)
Frequency 6000	46.5 (10.73)	53.88 (7.51)
Frequency 8000	50.50 (6.37)	54.25 (7.21)

Population analysed: 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.

Primary outcome: Aided Hearing Thresholds for Conductive Hearing Loss

Time frame: Day 14. Mean (Standard Deviation). Unit: hertz

Measure	Baha Softband n = 3	Adhear Post n = 3
Frequency 250	17.5 (3.54)	22.5 (3.54)
Frequency 500	12.5 (10.61)	25 (14.14)
Frequency 1000	22.5 (3.54)	17.5 (3.54)
Frequency 2000	27.5 (3.54)	35 (14.14)
Frequency 3000	35 (0)	47.5 (10.61)
Frequency 4000	37.50 (10.61)	55 (14.14)
Frequency 6000	40 (14.14)	50 (14.14)
Frequency 8000	47.5 (3.54)	57.5 (10.61)

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 506 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-Sided Deafness Adult (Aim1) Group	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Conductive Hearing Loss Adult (Aim 2) Group	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Adhear (Aim 3) Group	0 of 33 (0%)	0 of 33 (0%)	0 of 33
BAHA (Aim 3) Group	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hillary Snapp, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aided Hearing Thresholds for Single Sided Deafness (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.