Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Memory
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators evaluated hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) within one week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
详细描述
OpenSound Navigator (OSN) is a speech enhancement hearing aid algorithm developed by Oticon that utilizes an adaptive directional microphone system with an automatic gain control noise reduction program. This hearing aid feature is intended for adult hearing aid users and its potential benefits of speech, vocabulary and listening development in pediatric users has not been investigated. Here the investigators aim to evaluate the efficacy of OSN programming in pediatric hearing aid users (6-12 years of age) diagnosed with a symmetrical sensorineural hearing loss in the mild to moderately-severe range. The investigators used a within-subjects study design with pre- and post-comparisons. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids with the OSN feature enabled. Participants will undergo standard audiometric diagnostic testing and will be fit with the hearing aids by a licensed clinical audiologist. Participants are required to wear the hearing aids full time (at least 6 hours per day average) during the duration of the study. The evaluation measures will include speech recognition testing in controlled background noise and the Speech, Spatial and Qualities of Hearing Scale questionnaire (completed by parents/legal guardian). Testing will be performed within a week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children ages 6 to 12 years
- •English as the primary home language
- •positive for bilateral symmetrical mild to moderately-severe sensorineural hearing loss
- •currently using hearing aids that were dispensed at least 18 months prior to enrollment of the study
- •negative for major cognitive handicap or developmental delay that would prevent or restrict participation, as determined by the PI or designee
- •negative for learning disability, for example attention-deficit/hyperactivity disorder, as determined by the PI or designee
- •negative for serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
- •informed consent of parent/guardian
- •assent of participating child if aged 11 years and over
- •standard MRI inclusion criteria as set by the Cincinnati Children's Hospital Medical Center department of Radiology
- •not currently pregnant or breast feeding
- •willingness and ability of the participant and/or the participant's caregiver to comply with study requirements
- •no history of medical neglect of caregiver
排除标准
- 未提供
结局指标
主要结局
Memory
时间窗: 2 months
Long-term vocabulary memory and episodic memory were evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Picture Vocabulary test and the Picture Sequence Memory Test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Word Recognition in Quiet Abilities
时间窗: 2 months
Aided speech perception in quiet was evaluated within a week of hearing aid fitting and again after two months. Recorded sentences were presented at 50 dB SPL, and scoring was based on accuracy of each recited word.
Mathematic Academic Performance
时间窗: 2 months
Mathematic skills were evaluated using a standardized battery called the Woodcock-Johnson IV Test of Achievement (WJ-IV). Subtests included Applied Problems and Calculation. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Academic Language Performance
时间窗: 2 months
Language skills were evaluated using WJ-IV. Subtests included Letter-Word Identification and Passage Comprehension. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Word Recognition in Noise Abilities
时间窗: 2 months
Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal, the adaptive noise level changed to 2 dB increments. This continued for six more noise level reversals for an overall signal-to-noise ratio (SNR) threshold calculation. The final threshold score indicates the estimated SNR level in which the participant correctly recognizes monosyllabic words 50% of the time (SNR-50). This test was performed within a week of hearing aid fitting and again after two months.
Executive Function
时间窗: 2 months
Executive function was evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Flanker Inhibitory Control and Attention test and and the Dimensional Change Card Sort test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
次要结局
- Speech, Spatial Qualities of Hearing Scale (SSQ) Scores(2 months)
- Glasgow Hearing Aid Benefit Profile Scores(2 months)