Conductive Hearing LossACESNCT03143257

Ambispective Clinical Evaluation of Sophono™

An observational study of Conductive Hearing Loss and Single-Sided Deafness, run by Medtronic Surgical Technologies at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant. Read more about this study

Who is it for?: Ages 5 years and older
Conditions the study is for: Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss
What is being tested?: Sophono Bone Conduction Hearing Systems
Type of treatment: Medical device
How many people: 71 participants
Where: 6 sitesUnited States
Study dates: 29 Jun 2017to 31 May 2018
Phase: Observational
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 5 years and older
All sexes
Child, Adult, Older adult

Study population: The subject population for this study includes male and female patients 5 years of age and older who have received the Sophono implant. Subjects will be recruited from Investigators who have implanted Sophono systems or from other non-investigator physician referrals. Subjects are expected to represent a population diagnosed with conductive hearing loss (CHL), single-sided deafness (SSD), and mixed hearing loss (HL).

Who may be able to join

Any subject who currently has or who has had the Sophono implant (including those who have been explanted)
Has or has had Sophono implant for 3 months or longer

Who cannot join

Subject has implant but is unable or unwilling to perform audiologic testing
Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

UF Health ENT and Allergy
Gainesville, Florida, 32607
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
Park Avenue Otology/Neurotology
New York, New York, 10075
Macias Otology
Phoenix, Arizona, 85006
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, 15212
Carolina Ear & Hearing Clinic
Raleigh, North Carolina, 27609

Other trials in United States

About this study

Conditions: Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss
Being tested: Sophono Bone Conduction Hearing Systems
Medical subject headings: Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural

What participants receive

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

Sophono Bone Conduction Hearing SystemsDevice
The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of Bone Conduction (BC) of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea.
The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear.

Study groups in NCT03143257
Study group	Role	What they receive
Subjects		Diagnosed with Conductive Hearing Loss (CHL), Single-Sided Deafness (SSD)and mixed Hearing Loss (HL) who currently have or have had the Sophono implant Receives: Device: Sophono Bone Conduction Hearing Systems

What is being measured

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

Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant
The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam.
Measured: From Implantation to Study Visit, up to 6 years
Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor
The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry.
Measured: 1 day

Secondary outcomes (3)

Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor
All participants were tested with both the Alpha 2 and Alpha 2 MPO processor and also with no processor (Air Conduction) and a standard lab vibration device (Bone Conduction). The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor compared to the PTA aided by Alpha 2 MPO processor.
Measured: 1 day
Percentage of Participants Satisfied After System Use
Subject satisfaction, via non-validated satisfaction questions
Measured: 1 day
Assess QOL After System Use
QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment. The APHAB is a questionnaire with four subscales (Ease of Communication, Reverberation, Background Noise, and Aversiveness). Items are answered on a seven-point scale from "always" to "never". Scores for subscales can range from 0% (no difficulty) to 99% (maximum difficulty). Negative scores reflect a better benefit from aided hearing all subcategories are reported in percentiles. Abbreviated Profile of Hearing Aid Benefit was taken at 1 time point. Per request of site Institutional Review Board (IRB) pediatric patients were given a pediatric version. Calculation compared aided to unaided hearing.
A global score is computed by averaging the East of Communication, Reverberation, and Background Noise scale scores. Questions are answered for unaided and aided listening. Aided scores are subtracted from unaided scores.
Measured: 1 day

Timeline

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

29 Jun 201731 May 2018

First posted8 May 2017
Study start29 Jun 2017
Primary completion31 May 2018
Study completion31 May 2018

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 Conductive Hearing LossStudies 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: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03143257
Sponsor's protocol ID: MDT16043ENT
Acronym: ACES
Status last verified: Jan 2024
First submitted: 1 May 2017
Last updated: 5 Jul 2024
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

Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
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Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
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Evaluation of Flexible Conductive Hearing Aids
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RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
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Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
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All Conductive Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ambispective Clinical Evaluation of Sophono™
ClinicalTrials.gov ID: NCT03143257
Acronym / sponsor ID: ACES / MDT16043ENT
Conditions: Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss
Study type: Observational
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
Study start: 29 Jun 2017 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 8 May 2017 (actual)
Results: Posted 5 Jul 2024

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Subjects	–	Device: Sophono Bone Conduction Hearing SystemsDiagnosed with Conductive Hearing Loss (CHL), Single-Sided Deafness (SSD)and mixed Hearing Loss (HL) who currently have or have had the Sophono implant

Who may qualify

Ages: 5 years and older
Sex: All
Age groups: Child, Adult, Older adult
Study population: The subject population for this study includes male and female patients 5 years of age and older who have received the Sophono implant. Subjects will be recruited from Investigators who have implanted Sophono systems or from other non-investigator physician referrals. Subjects are expected to represent a population diagnosed with conductive hearing loss (CHL), single-sided deafness (SSD), and mixed hearing loss (HL).

Key inclusion criteria (2 listed)

Any subject who currently has or who has had the Sophono implant (including those who have been explanted)
Has or has had Sophono implant for 3 months or longer

Key exclusion criteria (2 listed)

Subject has implant but is unable or unwilling to perform audiologic testing
Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor

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
Sophono Bone Conduction Hearing SystemsThe Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of Bone Conduction (BC) of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea. The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear.	Device	Subjects

Primary outcome

Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant
Time frame: From Implantation to Study Visit, up to 6 years
The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam.
Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor
Time frame: 1 day
The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry.

3 secondary outcomes

Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor
Time frame: 1 day
Percentage of Participants Satisfied After System Use
Time frame: 1 day
Assess QOL After System Use
Time frame: 1 day

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sophono Implant	71	71

Primary outcome: Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant

Time frame: From Implantation to Study Visit, up to 6 years. Number (95% Confidence Interval). Unit: Proportion of Adverse Events

Measure	All Participants n = 71
Value	0.038 (0.018 to 0.070)

Primary outcome: Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor

Time frame: 1 day. Mean (Standard Deviation). Unit: decibles

Measure	None AC n = 67	None BC n = 67	Aided Alpha 2 n = 67	Aided Alpha 2 MPO n = 67
Value	79.1 (21.4)	41.2 (26.8)	39.4 (11.2)	35.7 (11.0)

None AC vs None BC: Mean Difference (Net): 38.0, p <0.0001, Wilcoxon (Mann-Whitney)
None AC vs Aided Alpha 2 MPO: Mean Difference (Net): 43.5, p <0.0001, Wilcoxon (Mann-Whitney)
Aided Alpha 2 vs Aided Alpha 2 MPO: Mean Difference (Net): 3.7, p < 0.0001, Wilcoxon (Mann-Whitney)

Population analysed: 69 participants had prospective data (72 ears) and no data was obtained for 2 subjects (deviations noted) so the number of ears analyzed was 70 (67 subjects).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from each subject at the single study visit which occurred at a range of 3 months to 5 years post-implantation. The collective Adverse Events in this study represent a range of time from implantation to the study visit (3 months to 5 years post implantation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 71 (0%)	9 of 71 (12.7%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Conductive Hearing Loss

Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
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

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Conductive Hearing Loss and Single-Sided Deafness, run by Medtronic Surgical Technologies at 6 sites in United States.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 5 Jul 2024). 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?

Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant (time frame: From Implantation to Study Visit, up to 6 years). The study lists 2 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 NCT03143257.

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 5 Jul 2024.