Study of the Hearing Performance and Comfort of a New Bone Conduction Hearing System - Comparison to the Osteo-integrated Bone Conduction Hearing Aid Mounted on a Headband: Prospective Open Multicenter Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Comfort
研究概览
简要总结
Main objectives
- The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
- The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.
Secondary objectives
- Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate the satisfaction and use of ADHEAR.
详细描述
Introduction
Hearing loss, or deafness, is defined by the decrease in the perception of sounds. Conductive hearing loss is characterized by damage to the outer or middle ear. Its etiologies are congenital, malformative or acquired, sequelae of infectious or inflammatory processes (chronic otitis).
They cause a defect in the transmission of the sound towards the cochlea. Conductive hearing loss can be compensated by bone conduction hearing aids or middle ear implants.
Osteo-integrated bone conduction hearing aids (Baha, Ponto) have become the standard of care for patients with conductive hearing loss when an acoustic hearing aid can't be used.
These prostheses are percutaneous but for children the implantation of the osseointegrated abutment requires that the child has developed a sufficient bone thickness. In general, surgery is not possible before the age of 5 years. [Doshi et al. 2012].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 5 and 15 years old.
- •Child for whom a bone conduction prosthesis test is indicated
- •conductive hearing loss: bone conduction ≤ 10 dB Hearing Level (HL)
- •Contralateral ear: air conduction ≤ 30 dB HL at 500, 1000, 2000, 3000 and 4000Hz
- •No test of conductive bone conduction hearing aid with softband in the 3 months preceding the study
- •No associated disorders
- •Child not already fitted with a bone conduction system
排除标准
- 未提供
研究组 & 干预措施
ADHEAR-PONTO
The ADHEAR system will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system. Then the patient will be fitted with the PONTO 3 SUPER POWER on softband and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband.
干预措施: ADHEAR and PONTO 3 SUPER POWER on softband hearing aids (Device)
PONTO-ADHEAR
The PONTO 3 SUPER POWER on softband will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband. Then the patient will be fitted with the ADHEAR system and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system.
干预措施: ADHEAR and PONTO 3 SUPER POWER on softband hearing aids (Device)
结局指标
主要结局
Comfort
时间窗: 15 days after fitting of the system and port at home
Perceived comfort will be measured with a visual analogue scale (VAS) of 10 cm overall comfort. The VAS will have the following anchors: 10 = very comfortable; 8 = comfortable; 6 = comfortable enough; 4 = uncomfortable; 2 = very uncomfortable; 0 = not comfortable at all
Average tonal gain (dB)
时间窗: 15 days after fitting of the system and port at home
The threshold of free-field tonal audiometry is measured in the free field with masking of the contralateral ear with and without the auditory system. The tonal gain is defined by the difference of the tonal threshold with / without the auditory system. The average tonal gain is defined by the average of the tonal gain at frequencies 500, 1000, 2000, 3000 and 4000 Hz.
次要结局
- Skin reactions(15 days after fitting of the system and port at home)
- Bone conduction thresholds (dB Hearing Level (HL))(at the inclusion and 30 days after)
- Subjective measurement of auditory perception(15 days after fitting of the system and port at home)
- Air conduction threshold (dB HL)(at the inclusion and 30 days after)
- Vocal audiometry in silence(15 days after fitting of the system and port at home)
- Measurement of satisfaction and use of ADHEAR(15 days after fitting of the system and port at home)
- Vocal audiometry in noise(15 days after fitting of the system and port at home)