Hearing Loss, Total Unilateral Deafness, Unilateral Hearing Loss
Conditions
Keywords
Hearing Loss, Unilateral Hearing Loss, Single Sided Deafness
Brief summary
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
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
DEVICESonitus SoundBite System
Non Surgical Bone Conduction Device
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 a history of seizures * 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 |
|---|---|---|
| Long Term Safety | 6 months | The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) | 3 months and 6 months | 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. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. 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 occurred in April 2010. Subjects were informed about the potential for participation via IRB approved flyers or by indicating interest on consent forms from other studies.
Participants by arm
| Arm | Count |
|---|---|
| Long Term Safety Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Long Term Safety |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 44.41 years STANDARD_DEVIATION 11.54 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Long Term Safety
The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Participants Experiencing no Adverse Events | Long Term Safety | 22 participants |
Secondary
Measurement of Device Benefit With the 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. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).
Time frame: 3 months and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Number of Participants Experiencing no Adverse Events | Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) | 21.3 Global Benefit Score | Standard Deviation 16.9 |
| Global Benefit APHAB Score Aided 6 Months | Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) | 23.1 Global Benefit Score | Standard Deviation 16 |