Status:
TERMINATED
Speech Locator_Benefits in Pediatric Popluations
Lead Sponsor:
Sonova AG
Conditions:
Hearing Loss
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief Summary
The study seeks to evaluate the impact of SpeechSensor and StereoZoom 2.0 on speech understanding in noise in dynamic listening conditions in pediatric hearing aid users.
Detailed Description
The purpose of this study is to substantiate clinical performance claims regarding the benefit of the SpeechSensor feature on speech recognition in noise for side and rear speech as well as StereoZoom...
Eligibility Criteria
Inclusion
- Experienced (\> 6 months), full-time hearing aid user
- 10 years up to but not including 18 years of age
- Spoken English
- Ability to understand oral instruction
- Ability to describe listening experiences
- No known neurological issues or cognitive impairment
- Ability to attend the in-person appointment(s)
- No speech/language deficits that could compromising ability to perform tasks
- Healthy outer and middle ear
- Hearing loss consistent with fitting range of the investigational product
- Access to a smartphone that can be used during a home trial
- Informed consent (signature) of parent and consent or assent (verbal) of child
Exclusion
- Clinical contraindications (e.g., closed ear canal, absence of pinna)
- Known hypersensitivity or allergy to materials comprising hear-ing aid or acoustic coupling
- Unwilling to wear the hearing aid
- Unwilling or not permitted to use a smartphone
- Aided open-set aided speech recognition scores for speech front (+15 dB SNR) \< 30%
Key Trial Info
Start Date :
June 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06533774
Start Date
June 8 2023
End Date
October 31 2023
Last Update
August 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hearts for Hearing
Oklahoma City, Oklahoma, United States, 73120