Standard PMCF Study WSA @ HZO
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 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (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
- •Hearing loss should fall within fitting range of study hearing aid
- •They should be experienced hearing aid users
- •Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
- •Sensorineural HL, mild-to-moderate
- •HL corresponding to the fitting range of the hearing aid
- •Healthy (outer) ear
- •Older than 18 years
- •German is mother tongue
- •Able to understand the instructions
- •Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
- •Informed consent
排除标准
- •Contraindication for hearing aid treatment
- •Fluctuating or rapidly progressing hearing loss
- •"Central" hearing problems
- •Limited mobility
- •Limited dexterity (in handling the hearing aid)
- •Known psychological problems
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 (SRT in dB). 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. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
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 (SRT in dB). 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. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
次要结局
- Freiburger Monosyllabic Speech Test(Estimated Time Frame 2 weeks (Test conducted at second lab session).)
- Match-to-Target(1 day (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)
- Freiburger Monosyllabic Speech Test(Estimated Time Frame 2 weeks (Test conducted at second lab session).)
- Match-to-Target(1 day (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)