Unilateral Hearing LossNCT00977314
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
A study testing The Sonitus Bone Conduction Hearing System, SoundBite and SoundBite Hearing System in people with Unilateral Hearing Loss, run by Sonitus Medical Inc at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unilateral Hearing Loss
- What is being tested?
- The Sonitus Bone Conduction Hearing System, SoundBite and SoundBite Hearing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Feb 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be >18, < 80 years old
- Must be fluent in English, as determined by the PI
- Must not be a member of a vulnerable group (IRB defined)
- Must remain in geographic area during duration of the study
- Diagnosis of acquired SSD (Section 3.1), time since onset (≥3 mos)
- Must have a minimum of 6 posterior teeth remaining in the upper arch (3 teeth per side),third molars are acceptable if healthy, fully erupted and substituting for second molars
Who cannot join
- Must not be current users of devices such as Baha, CROS or TransEar
- Must not have known active medical causes of SSD:
- Active middle ear pathology
- Conductive HL (Otosclerosis, otitis media, otitis externa and others)
- Sudden hearing loss that is not stable
- Must not have known medical problems that might be life-threatening or is a contraindication for elective dental or medical procedures
Show all 23Show fewer
- Must not have known problems that may interfere with the impression procedure, such as inability to breath through nose (e.g. severe flu, allergies or cold)
- Must not have allergies to polymers
- Must not have known dental abnormalities:
- Temporary crowns or undergoing dental treatment
- Poor oral hygiene and/or rampant decay
- Current orthodontics
- Active caries in one or more of the possible abutment teeth for the device
- Active moderate to severe periodontal disease around abutment teeth for the device
- Suspicious oral/facial lesions or swelling of any type
- Severe pain on palpation on any area of mouth, face or neck
- Moderate to severe heat sensitivity on any of the upper teeth
- Subject currently being treated for temporomandibular joint disorder (TMJ), pain, full mouth reconstruction or posterior dental implants
- Must not have known Audiological conditions:
- Conductive hearing loss (air-bone gap >10dB HL at more than 3 frequencies)
- Word recognition scores inconsistent with pure tone averages
- Fluctuating hearing loss
- Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hearing Resource Center
Redwood City, California, 94063
Camino Ear Nose and Throat
San Jose, California, 95123
About this study
The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).
Read the detailed description
The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled calibration software for subject calibration. The Sonitus BCD picks up sounds from a microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the natural pinna and ear canal. The signal picked up by the microphone is then transmitted wirelessly to a removeable bone conduction oral appliance located on the upper molars. The oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory signal to the teeth that reaches the skull via bone conduction and routed transcranially to the contralateral cochlea.
- Conditions
- Unilateral Hearing Loss
- Being tested
- The Sonitus Bone Conduction Hearing System, SoundBite, SoundBite Hearing System
- Keywords
- Unilateral Hearing Loss
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Sonitus Bone Conduction Hearing SystemDevice
Comparison of HINT scores (Speech front with noise at better ear) at 30 days tested with the device in place verses with the device removed.
SoundBiteDevice
SoundBite Hearing SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| SoundBite Hearing System | Experimental | The objective of this study was to assess the safety and effectiveness of the SoundBite hearing system by Sonitus Medical and to support its intended use for the treatment of unilateral hearing loss. The SoundBite hearing system is a Bone Conduction Device (BCD) and is occasionally referred to as such in the protocol and within this report. Receives: Device: The Sonitus Bone Conduction Hearing System; Device: SoundBite; Device: SoundBite Hearing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device- and Procedure-related Adverse Events at 30 Days
The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:
Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination.
Measured: 30 days
Efficacy: Ability to Understand Speech in Noise
The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.
Measured: Day 1, Day 30
Secondary outcomes (1)
Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).
The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Unilateral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonitus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Murray, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977314
- Sponsor's protocol ID
- CLN002
- Status last verified
- Oct 2014
- First submitted
- 14 Sep 2009
- Last updated
- 17 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ozer E, Adelman C, Freeman S, Sohmer H. Bone conduction hearing on the teeth of the lower jaw. J Basic Clin Physiol Pharmacol. 2002;13(2):89-96. doi: 10.1515/jbcpp.2002.13.2.89.
PubMed 16411423Soli SD, Wong LL. Assessment of speech intelligibility in noise with the Hearing in Noise Test. Int J Audiol. 2008 Jun;47(6):356-61. doi: 10.1080/14992020801895136. No abstract available.
PubMed 18569108Dahlin GC, Allen FG, Collard EW. Bone-conduction thresholds of human teeth. J Acoust Soc Am. 1973 May;53(5):1434-7. doi: 10.1121/1.1913490. No abstract available.
PubMed 4712563Wazen JJ, Spitzer J, Ghossaini SN, Kacker A, Zschommler A. Results of the bone-anchored hearing aid in unilateral hearing loss. Laryngoscope. 2001 Jun;111(6):955-8. doi: 10.1097/00005537-200106000-00005.
PubMed 11404603Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, Cox K, Brackmann DE, Soli SD. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg. 2003 Sep;129(3):248-54. doi: 10.1016/S0194-5998(03)00527-8.
PubMed 12958575Stenfelt SP, Hakansson BE. Sensitivity to bone-conducted sound: excitation of the mastoid vs the teeth. Scand Audiol. 1999;28(3):190-8. doi: 10.1080/010503999424761.
PubMed 10489868Murray M, Miller R, Hujoel P, Popelka GR. Long-term safety and benefit of a new intraoral device for single-sided deafness. Otol Neurotol. 2011 Oct;32(8):1262-9. doi: 10.1097/MAO.0b013e31822a1cac.
PubMed 21799455Miller R, Hujoel P, Murray M, Popelka GR. Safety of an intra-oral hearing device utilizing a split-mouth research design. J Clin Dent. 2011;22(5):159-62.
PubMed 22403981Popelka GR, Derebery J, Blevins NH, Murray M, Moore BC, Sweetow RW, Wu B, Katsis M. Preliminary evaluation of a novel bone-conduction device for single-sided deafness. Otol Neurotol. 2010 Apr;31(3):492-7. doi: 10.1097/MAO.0b013e3181be6741.
PubMed 19816229Murray M, Popelka GR, Miller R. Efficacy and safety of an in-the-mouth bone conduction device for single-sided deafness. Otol Neurotol. 2011 Apr;32(3):437-43. doi: 10.1097/MAO.0b013e3182096b1d.
PubMed 21221045
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
- ClinicalTrials.gov ID
- NCT00977314
- Acronym / sponsor ID
- CLN002
- Conditions
- Unilateral Hearing Loss
- Keywords
- Unilateral Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sonitus Medical IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).
Detailed description
The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled calibration software for subject calibration. The Sonitus BCD picks up sounds from a microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the natural pinna and ear canal. The signal picked up by the microphone is then transmitted wirelessly to a removeable bone conduction oral appliance located on the upper molars. The oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory signal to the teeth that reaches the skull via bone conduction and routed transcranially to the contralateral cochlea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SoundBite Hearing System | Experimental | Device: The Sonitus Bone Conduction Hearing System, Device: SoundBite, Device: SoundBite Hearing SystemThe objective of this study was to assess the safety and effectiveness of the SoundBite hearing system by Sonitus Medical and to support its intended use for the treatment of unilateral hearing loss. The SoundBite hearing system is a Bone Conduction Device (BCD) and is occasionally referred to as such in the protocol and within this report. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be >18, < 80 years old
- Must be fluent in English, as determined by the PI
- Must not be a member of a vulnerable group (IRB defined)
- Must remain in geographic area during duration of the study
- Diagnosis of acquired SSD (Section 3.1), time since onset (≥3 mos)
Key exclusion criteria (23 listed)
- Must not be current users of devices such as Baha, CROS or TransEar
- Must not have known active medical causes of SSD:
- Must not have known medical problems that might be life-threatening or is a contraindication for elective dental or medical procedures
- Must not have known problems that may interfere with the impression procedure, such as inability to breath through nose (e.g. severe flu, allergies or cold)
- Must not have allergies to polymers
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 |
|---|---|---|
| The Sonitus Bone Conduction Hearing SystemComparison of HINT scores (Speech front with noise at better ear) at 30 days tested with the device in place verses with the device removed. | Device | SoundBite Hearing System |
| SoundBite | Device | SoundBite Hearing System |
| SoundBite Hearing System | Device | SoundBite Hearing System |
Primary outcome
Incidence of Device- and Procedure-related Adverse Events at 30 Days
Time frame: 30 days
The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included: Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination.
Efficacy: Ability to Understand Speech in Noise
Time frame: Day 1, Day 30
The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.
1 secondary outcome
Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16411423Ozer E, Adelman C, Freeman S, Sohmer H. Bone conduction hearing on the teeth of the lower jaw. J Basic Clin Physiol Pharmacol. 2002;13(2):89-96. doi: 10.1515/jbcpp.2002.13.2.89.
- Background: PubMed 18569108Soli SD, Wong LL. Assessment of speech intelligibility in noise with the Hearing in Noise Test. Int J Audiol. 2008 Jun;47(6):356-61. doi: 10.1080/14992020801895136. No abstract available.
- Background: PubMed 4712563Dahlin GC, Allen FG, Collard EW. Bone-conduction thresholds of human teeth. J Acoust Soc Am. 1973 May;53(5):1434-7. doi: 10.1121/1.1913490. No abstract available.
- Background: PubMed 11404603Wazen JJ, Spitzer J, Ghossaini SN, Kacker A, Zschommler A. Results of the bone-anchored hearing aid in unilateral hearing loss. Laryngoscope. 2001 Jun;111(6):955-8. doi: 10.1097/00005537-200106000-00005.
- Background: PubMed 12958575Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, Cox K, Brackmann DE, Soli SD. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg. 2003 Sep;129(3):248-54. doi: 10.1016/S0194-5998(03)00527-8.
- Background: PubMed 10489868Stenfelt SP, Hakansson BE. Sensitivity to bone-conducted sound: excitation of the mastoid vs the teeth. Scand Audiol. 1999;28(3):190-8. doi: 10.1080/010503999424761.
- Background: PubMed 21799455Murray M, Miller R, Hujoel P, Popelka GR. Long-term safety and benefit of a new intraoral device for single-sided deafness. Otol Neurotol. 2011 Oct;32(8):1262-9. doi: 10.1097/MAO.0b013e31822a1cac.
- Background: PubMed 22403981Miller R, Hujoel P, Murray M, Popelka GR. Safety of an intra-oral hearing device utilizing a split-mouth research design. J Clin Dent. 2011;22(5):159-62.
- Background: PubMed 19816229Popelka GR, Derebery J, Blevins NH, Murray M, Moore BC, Sweetow RW, Wu B, Katsis M. Preliminary evaluation of a novel bone-conduction device for single-sided deafness. Otol Neurotol. 2010 Apr;31(3):492-7. doi: 10.1097/MAO.0b013e3181be6741.
- Results publication: PubMed 21221045Murray M, Popelka GR, Miller R. Efficacy and safety of an in-the-mouth bone conduction device for single-sided deafness. Otol Neurotol. 2011 Apr;32(3):437-43. doi: 10.1097/MAO.0b013e3182096b1d.
- SoundBite Hearing DeviceLink provided by the sponsor.
- Sonitus Medical Corporate PageLink provided by the sponsor.
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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.
Michael Murray, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Sonitus Bone Conduction Hearing System, SoundBite and SoundBite Hearing System in people with Unilateral Hearing Loss, run by Sonitus Medical Inc at 2 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 6 inclusion and 23 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 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 17 Oct 2014). 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?
Incidence of Device- and Procedure-related Adverse Events at 30 Days (time frame: 30 days). 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 NCT00977314, which also lists 10 linked publications.
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 17 Oct 2014; AzTrials last refreshed its copy on 26 Oct 2026.