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| Name | Class |
|---|---|
| AccuData Solutions | UNKNOWN |
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This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyric self-replacement | Experimental | This cohort of experienced Lyric patients are required to meet the candidacy criteria to be eligible for the self-replacement procedure. They will also be required to demonstrate proficiency with the self-replacement procedure before proceeding with independent self-replacement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Lyric self-replacement procedure | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aided audiometric threshold testing between standard and experimental replacement procedures | 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. | Baseline, during intervention, immediately after intervention |
| Change in aided speech-in-noise testing between standard and experimental replacement procedures | 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. | Baseline, during intervention, immediately after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures | 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 | Through study completion, an average of 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in incidence of provider/clinical support needed across device replacement procedures | 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 | Through study completion, an average of 5 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Gardner, AuD | Sonova USA Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Audiology | San Francisco | California | 94108 | United States | ||
| NYC Hearing Associates |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
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| Change in incidence of acoustic feedback across device replacement procedures | 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 | Baseline, during intervention, immediately after intervention |
| Change in measured device position at replacement between standard and experimental replacement procedures | 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. | Baseline, during intervention, immediately after intervention |
| New York |
| New York |
| 10018 |
| United States |
| Aim Hearing and Audiology | Greensboro | North Carolina | 27410 | United States |
| ENT & Audiology Associates | Raleigh | North Carolina | 27612 | United States |
| The Woodlands Hearing Center | The Woodlands | Texas | 77384 | United States |
| Bay Area Audiology and Hearing Aids | Webster | Texas | 77598 | United States |
| Richmond Hearing Doctors | Midlothian | Virginia | 23114 | United States |
| Richmond Hearing Doctors | Richmond | Virginia | 23226 | United States |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |