Long Term Safety of the Sonitus SoundBite System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Long Term Safety
研究概览
简要总结
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Long Term Safety
时间窗: 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.
次要结局
- Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)(3 months and 6 months)