Hearing Loss
Conditions
Brief summary
This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.
Interventions
DEVICEPhonak Lyric self-replacement procedure
The self-replacement procedure is an experimental procedure in which the Lyric user replaces the Lyric devices independently at every other device replacement, using dedicated candidacy, training, and management procedures, conducted by and at the discretion of his/her hearing care provider (HCP).
Sponsors
AccuData Solutions
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Meets requirements outlined on Lyric self-replacement candidacy form * Current Lyric hearing instrument user with 3+ months of Lyric experience * 22 years of age or older at the time of enrollment in the study * Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally) * 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 self-replacement candidacy form * 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 local regulations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in aided audiometric threshold testing between standard and experimental replacement procedures | Baseline, during intervention, immediately after intervention | Aided audiometric test measures: threshold testing. Thresholds will be measured in decibels Hearing Level (dBHL), with a range of -10 - 120 dBHL. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures. |
| Change in aided speech-in-noise testing between standard and experimental replacement procedures | Baseline, during intervention, immediately after intervention | Aided audiometric test measures: speech-in-noise testing. Scores will be measured using signal-to-noise ratio loss, with scores ranging from 0 - 25.5. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures | Through study completion, an average of 5 months | Evaluation of incidence of medical referral secondary to device replacement, as determined necessary by the hearing care professional, and compared between the standard and experimental device replacement procedures |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in incidence of provider/clinical support needed across device replacement procedures | Through study completion, an average of 5 months | Evaluation of incidence of provider/clinical support needed between device replacements, as recorded by study staff, and compared between time periods associated with the standard and experimental device replacement procedures |
| Change in incidence of acoustic feedback across device replacement procedures | Baseline, during intervention, immediately after intervention | Evaluation of incidence of acoustic feedback secondary to device replacement, as subjectively reported by the end user, and compared between the standard and experimental device replacement procedures |
| Change in measured device position at replacement between standard and experimental replacement procedures | Baseline, during intervention, immediately after intervention | Achieved insertion depth of device, as measured by the hearing care professional using the dedicated fitting tool, and compared between the standard and experimental fitting procedures. |
Countries
United States
Outcome results
None listed