Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).
研究概览
简要总结
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits.
The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study.
Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016.
The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower.
The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
- •Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
- •Adult subjects (18 years or older)
- •Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed
排除标准
- •There are no exclusion criteria in this study due to the retrospective nature of the study.
结局指标
主要结局
Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).
时间窗: Visit 2, 3 months
Functional gain is the difference between the average unaided threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz and the average aided (i.e. with the Ponto 3 SuperPower) threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.
次要结局
- Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.(Visit 1, Day 1)
- Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL(Visit 2, 3 months)
- Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD(Visit 2, 3 months)
- Individual Level Evaluation of Objectives 1-6; Improved Hearing(Change between visit 1 (day 1) and visit 2 (3 months)t of study)
- Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL(Visit 1 day 1)
- Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.(visit 2, 3 months)
- Quality of Life Improvements With the Ponto 3 SuperPower(Visit 2, 3 months)
- Skin Condition Assessment Around the Abutment(Visit 2, 3 months)