Sensorineural Hearing Loss
Conditions
Keywords
extended wear hearing aid
Brief summary
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.
Detailed description
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. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.
Interventions
DEVICEExtended Wear Hearing Aid
Extended 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.
Sponsors
The Woodlands Hearing Center
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single group of participants will be fit with the extended wear hearing devices and will be tested in both the aided and unaided conditions in various tasks. Conditions will be counterbalanced and all participants will experience the same conditions. Conditions will include unaided, aided with pre-calculation A, and aided with pre-calculation B.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Good understanding (read/write/speak) of the English language * Willingness to comply with all study requirements
Exclusion criteria
* 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 * Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NASA Task Load Index (NASA-TLX) | Day 1 of 1 day study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AZBio Speech in noise testing | Day 1 of 1 day study | 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. |
Countries
United States
Contacts
Primary ContactStudy Manager
Outcome results
None listed