Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
ConditionSensorineural Hearing Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonova AG
About this trial
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets requirements outlined on Lyric Candidacy Form
Current Lyric hearing instrument user
18 years of age or older at time of enrollment in the study
Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
Disqualifiers
Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
Difficulty understanding/reading instructions when corrected for vision loss
Impairments that would restrict participation in any of the evaluations
Ear health conditions present at baseline that prevent immediate device replacement
Trial design
Design model
Single group
Treatments tested in this trial
Extended Wear Hearing Aid
DeviceExtended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
NASA Task Load Index (NASA-TLX)
A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.
Time frame
Day 1 of 1 day studySecondary outcomes
1
AZBio Speech in noise testing
The percentage of words correctly repeated by the participant when listening to sentences played from a front speaker at a certain dB level, while background noise is presented simultaneously from four corner speakers. A higher percentage indicates better speech understanding in noise.
Time frame
Day 1 of 1 day studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sonova AG
Lead sponsor
The Woodlands Hearing Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: