Unilateral Hearing Loss
Conditions
Keywords
Unilateral Hearing Loss
Brief 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).
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.
Interventions
DEVICEThe Sonitus Bone Conduction Hearing System
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.
DEVICESoundBite
DEVICESoundBite Hearing System
Sponsors
Sonitus Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device- and Procedure-related Adverse Events at 30 Days | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB). | 30 days | 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) |
Countries
United States
Participant flow
Recruitment details
Recruitment/Enrollment Phase(September 2009-November 2009) Location: Medical Clinics Meant to assess the subjects' ability to be enrolled in the trial, included Medical, Audiological and Dental evaluations.
Pre-assignment details
Phase 1: Enrollment: Assesses the subjects' ability to be enrolled in the trial. It included medical, audiological, and dental evaluations and device fit to ensure comfort during the duration of the trial.
Participants by arm
| Arm | Count |
|---|---|
| Analyzed Group A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it. | 30 |
| Pilot Group A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it. | 5 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Pilot Group | Analyzed Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 29 Participants | 34 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 8.1 | 46.6 years STANDARD_DEVIATION 13 | 46.5 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 5 participants | 30 participants | 35 participants |
| Sex: Female, Male Female | 3 Participants | 15 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 15 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
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.
Time frame: Day 1, Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical, Dental, Audiological Safety 30 Days | Efficacy: Ability to Understand Speech in Noise | -2.5 dB | Standard Deviation 1 |
Comparison: The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).p-value: <0.001t-test, 2 sided
Primary
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical, Dental, Audiological Safety 30 Days | Incidence of Device- and Procedure-related Adverse Events at 30 Days | 0 participants |
Secondary
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)
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical, Dental, Audiological Safety 30 Days | Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB). | 18.80 Global Benefit Score | Standard Deviation 13.36 |