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| Name | Class |
|---|---|
| Starkey Laboratories, Inc | INDUSTRY |
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The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fall risk assessment | Experimental | Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk. |
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| Speech intelligibility | Experimental | Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aids equipped with motion sensing abilities | Device | Participants will wear hearing aids that will assess their movement, and fall risk. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fall risk assessment using CDC's STEADI protocol | Participants will undergo the Centers for Disease Control and Prevention (CDC)'s STEADI (Stopping Elderly Accidents, Deaths & Injuries) fall risk assessment with the hearing aids on. The scoring for these tests will be done by the tester, 2 independent raters, and the hearing aids. A comparison of the fall risk assessments by the testers and the hearing aids is the primary outcome measure. This outcome is assessed in Fall Risk Assessment participants only. | approximately 15 minutes to assess |
| Timed Up and Go Test | Duration of time to stand, walk to a line on the floor (3 meters/10 feet away), turn around, return to chair and sit. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only. | approximately 15 minutes to assess |
| 30-Second Chair Stand Test | Number of times participants can stand without using their arms during the test. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only. | approximately 15 minutes to assess |
| 4-Stage Balance Test | Participants who are able to keep their balance for 10 second in each of four positions (feet together, feet staggered, feet in tandem, and single foot stand). They can hold their arms out, or move their body to help keep your balance, but not move their feet. This outcome is assessed in Fall Risk Assessment participants only. | approximately 15 minutes to assess |
| Consonant-Nucleus-Consonant (CNC) | The number and percentage of words and phonemes accurately repeated are measured in aided (using hearing aids) and unaided conditions. This outcome is measured in Speech Intelligibility participants only. |
| Measure | Description | Time Frame |
|---|---|---|
| Fall screening questionnaire using CDC's STEADI protocol | Participants are screened using the CDC's "Three Key Questions" which are part of the STEADI Protocol. | Approximately 2 minutes. |
| Listening Effort Questionnaire Scale Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Ear Institute | Recruiting | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33284647 | Background | Rahme M, Folkeard P, Scollie S. Evaluating the Accuracy of Step Tracking and Fall Detection in the Starkey Livio Artificial Intelligence Hearing Aids: A Pilot Study. Am J Audiol. 2021 Mar 10;30(1):182-189. doi: 10.1044/2020_AJA-20-00105. Epub 2020 Dec 7. | |
| 31914373 | Background | Burwinkel JR, Xu B, Crukley J. Preliminary Examination of the Accuracy of a Fall Detection Device Embedded into Hearing Instruments. J Am Acad Audiol. 2020 Jun;31(6):393-403. doi: 10.3766/jaaa.19056. Epub 2020 Aug 3. |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D004244 | Dizziness |
| D014717 | Vertigo |
| D013065 | Speech Intelligibility |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Approximately 10-15 minutes. |
| Quick Speech-in-Noise (QuickSIN) | The number and percentage of words and phonemes accurately repeated are measured in ambient noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only. | Approximately 10-15 minutes. |
| Words-in-Noise (WIN) | The number and percentage of words and phonemes accurately repeated are measured in muli-talker babble noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only. | Approximately 10-15 minutes. |
| Nonsense Syllable Test (NST) | The number and percentage of words and phonemes accurately repeated are measured in continuous noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only. | Approximately 10-15 minutes. |
Listening effort scale score measures the participant's perceived listening effort. This outcome is measured in Speech Intelligibility participants only.
| Approximately 5 minutes. |
| Auditory Lifestyle and Demand Scale Score | Auditory Lifestyle and Demand scale score measures perceived demands of hearing on lifestyle. This outcome is measured in Speech Intelligibility participants only. | Approximately 5 minutes. |
| User Experience Questionnaire | Participants rate their experience with the hearing aid regarding the following aspects: perceived difficulty communicating and listening effort in different environments. | Approximately 2 minutes. |
| Demographic and Health Questionnaires | Data is gathered on age, sex, education level, hand-laterality, professional background, exercise habits, race, ethnicity, marital status, health literacy scores, medical conditions, and medications. | Approximately 15 minutes. |
| Orthostatic Blood Pressure | Blood pressure measurements in laying down, sitting, and standing positions. | Approximately 15 minutes. |
| Pure-Tone Audiometry | Hearing thresholds are measured from 250Hz through 8kHz in both ears, air and bone conduction. | Approximately 15 minutes. |
| Activities-Specific Balance Confidence Questionnaire | Participants rate their confidence level in various balance situations. | Approximately 10 minutes. |
| Speech, Spatial Qualities of Hearing Scale (SSQ) | Participants rate their difficulty level with understanding speech in various hearing situations. | Approximately 10 minutes. |
| Hearing Aid Data | Data is gathered from the participants' hearing aids on wear-time, streaming time, time spent in various sound classes and software updates. Data is also collected on the participants' required receiver length and coupling, as well as any specific fitting requirements they may have. | Approximately 5 minutes. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D013060 | Speech |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |