Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use.
研究概览
简要总结
The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.
Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.
The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.
详细描述
This is a post market clinical follow up (PMCF) study with the purpose of gather knowledge on the use and performance of the Ponto 4 device on existing Ponto 4 users. The study does not include any treatment or fitting of new devices, instead the real-life application of the use of Ponto 4 on subjects already using Ponto 4(s) are investigated.
The Investigational Device used in the study is Ponto 4, a CE marked, and FDA cleared bone anchored hearing solution, produced by Oticon Medical AB and commercially available since June 2019.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 4 device as a minimum 1.5 month prior to the study. 20 patients, including minors down to 12 years old, with a conductive, mixed hearing loss or single-sided deafness will be included. The rationale for including minors is that they are also users of the device, and it is found important to collect data from their experience of using the device as well.
The study is a retrospective and prospective, multi-center study. It has one visit of 2,5-3 hours for adult subjects ≥18 years old. To minimize the burden and risks of tiredness for the minor subjects from 12-17 years old, the protocol activities can be divided into two visits. The decision will be based on the Investigators discretion.
The majority of the objectives of the study are prospectively collected whereas the BC In-situ (hearing with the Ponto 4 on) and audiometric data from the time of the fitting of Ponto 4, are collected retrospectively from the time of the fitting of Ponto 4 (aka the fitting visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •12 years old and above
- •Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study
- •Fluent in local language, as judged by the investigator
排除标准
- •Participation in another clinical investigation which might cause interference with study participation.
- •Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion
研究组 & 干预措施
single arm
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
干预措施: Audiometry (Device)
结局指标
主要结局
To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use.
时间窗: The outcome measure was assessed during Study Visit 1 (Day 1).
Functional gain with Ponto 4, i.e. the difference between average unaided and aided sound field thresholds. The functional gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz.
次要结局
- B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).(The outcome measure was assessed during Study Visit 1 (Day 1).)
- G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).(The assessment for this outcome measure was based on the BC in situ test conducted during a visit at least 6 weeks prior to Study Visit 1 (data collected retrospectively), and an aided sound field thresholds test conducted on Study Visit Day 1.)
- I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear).(Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1).)
- J. To Assess if a Patient's With CHL/MHL Hearing Loss Has Degraded to Being Outside Fitting Range on the Implanted Ear(s).(fitting visit ≥6 weeks prior to study visit)
- K. To Asses if Patients' With CHL/MHL Air to Bone Gap (PTA4) Has Increased/Decreased on the Implanted Ear(s)(Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1).)
- C. To Assess the Improvement of Speech Recognition With Ponto 4 on the Implanted Ear(s).(The outcome measure was assessed during Study Visit 1 (Day 1).)
- H. To Evaluate the Above Objectives on Individual Levels(The outcome measure was assessed during Study Visit 1 (Day 1).)