WSA Standard PMCF Study 2025
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- WSAUD A/S
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Oldenburg Sentence Test
研究概览
简要总结
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.
详细描述
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and undergo two 2-weeks home trials of the test hearing aid (with questionnaires).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensorineural hearing loss, mild-to-moderately severe (Pure tone average of 500, 1000, 2000 and 4000 Hz <65).
- •Hearing loss should fall within fitting range of study hearing aid
- •Subjects should be experienced hearing aid users who have had and used hearing aids daily for at least 1 year.
- •Air-Bone-Gap should be less or equal to 20 dB.
- •Asymmetry between left and right ear should not exceed 20dB for frequencies in the range of 250Hz to 4kHz
- •Healthy (outer and middle) ear
- •Older than 18 years
- •German is mother tongue
- •Able to understand the instructions
- •Willing to participate in laboratory tests and to wear the study HAs at home for 2 weeks
- •Informed consent
排除标准
- •Contraindication for HA treatment
- •Fluctuating or rapidly progressing hearing loss
- •"Central" hearing problems
- •Limited mobility
- •Limited dexterity (in handling the HA)
- •Known psychological or cognitive problems
- •Subjects must not show any injuries or a complete perforation of the ear drum. This must be clarified prior to the beginning of the study by means of otoscopy.
- •Subjects should be in good overall medical condition (e.g., they shall not suffer from dementia) and should not use medical treatments that might affect study results.
结局指标
主要结局
Oldenburg Sentence Test
时间窗: Estimated Time Frame 2 weeks (Test conducted at second lab session).
The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold in quiet and in noise. Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired.
次要结局
- Freiburger Monosyllabic Speech Test(Estimated Time Frame 2 weeks (Test conducted at second lab session).)
- Match-to-Target(Day 1 (Fitting procedure with real-ear measurements is done at first lab session))
- Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)(2 weeks)
- International Outcome Inventory for Hearing Aids (IOI-HA)(2 weeks)
- Satisfaction Questionnaire(2 weeks)
- Basic User need questionnaire(2 weeks)