Systems and methods for the screening and monitoring of inner ear function
Inventors
Fausti, Stephen • Ellingson, Roger • Helt, Wendy • Jacobs, Peter • Silaski, Grayson • Wilmington, Debra • Gordon, Samuel • Dille, Marilyn • McMillan, Garnett • Reavis, Kelly • Martin, Dawn
Assignees
US Department of Veterans Affairs
Publication Number
US-9339216-B2
Publication Date
2016-05-17
Expiration Date
2033-03-15
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Abstract
Methods and systems for monitoring or testing the hearing of a user using a portable unit include presenting a plurality of test frequencies for selection by a user and storing data about those frequencies, and the user's response to stimuli presented at those frequencies, and comparing the stored data to previously acquired hearing data. Using mathematical prediction algorithms, changes in baseline hearing values can be used to identify potential hearing issues, especially hearing issues associated with ototoxicity.
Core Innovation
The invention provides methods and systems for monitoring or testing the hearing of a user using a portable unit that presents a plurality of test frequencies for selection by the user, stores data about those frequencies and the user's response to stimuli presented at those frequencies, and compares the stored data to previously acquired hearing data. These systems use mathematical prediction algorithms to identify changes in baseline hearing values that can indicate potential hearing issues, particularly hearing loss associated with ototoxicity.
The systems and methods enable early detection and monitoring of inner ear damage, especially ototoxic-induced hearing loss and sensorineural damage. They include a portable audiometer capable of both automatic and manual operation, precision pure-tone stimulus generation up to 20 kHz, and remote transfer of health status information to healthcare professionals. The methods involve establishing a sensitive range for ototoxicity (SRO) for each ear, storing baseline hearing thresholds, performing subsequent tests comparing to baseline, and calculating clinically relevant changes with mathematical models incorporating risk factors.
The problem addressed is the lack of practical, effective hearing loss screening and monitoring especially for ototoxicity in patients undergoing treatment, such as cancer patients receiving ototoxic drugs. Existing audiometric equipment requires sound-attenuated rooms and clinical visits which are impractical for ill, fatigued, or remote patients, delaying early detection of hearing damage. There is also a need for non-invasive tests of outer hair cell function and neural survival that can be used outside clinical environments to prevent permanent hearing loss through timely intervention.
Claims Coverage
The claims include one independent claim that defines a method for monitoring or testing hearing, detailing the main inventive steps and features of the system and method.
Method for monitoring or testing hearing with user selection of test frequencies
Presenting multiple test frequencies for user selection through a display or acoustically, receiving user indications of selected frequencies including ear selection, and causing an audio test unit to output test sounds at selected frequencies and stimulus levels.
Storing and monitoring sensitive range for ototoxicity
Storing the highest set of test frequencies for which responses indicating hearing were received as the sensitive range for ototoxicity for each ear, storing baseline values based on stimulus levels, performing subsequent tests to monitor changes by comparing baseline and current values, and calculating whether significant changes have occurred.
Remote operation and data communication
Use of a computing device, such as a smartphone or tablet, running software to control the audio test unit, delivering wireless signals to cause test sounds to output, performing acoustic calibration and performance verification, network data receipt and secure communication with healthcare providers, optionally excluding identifying data and using encryption.
Use of multiple stimulus types and ambient noise management
Test sounds comprising pure tones, clicks, chirps, noise, or speech; measuring ambient noise levels and indicating whether noise exceeds thresholds; optionally employing noise cancellation to improve test reliability and sensitivity.
The claims together cover a comprehensive method and system for personalized hearing monitoring that includes user interaction for frequency selection, accurate storage and monitoring of the sensitive range for ototoxicity, remote operation and data transfer functionalities, as well as acoustic calibration and environmental noise management to ensure reliable and early detection of hearing changes.
Stated Advantages
Enables early detection and monitoring of ototoxic and other hearing damage efficiently and reliably, especially in remote or non-clinical settings.
Provides a portable, handheld system that moves testing out of the clinic to bedside, home, or remote locations, saving clinician, patient, and nursing time and reducing patient health risks.
Supports a personalized sensitive range for ototoxicity testing that reduces testing time and increases sensitivity to early hearing changes.
Allows patients to self-test using automated modes, increasing access and reducing need for professional audiologist time.
Integrates acoustic calibration, ambient noise monitoring, and noise cancellation to ensure accurate and standardized test results.
Facilitates remote communication of test results to healthcare professionals via secure, HIPAA-compliant networks, improving monitoring and clinical decision-making.
Documented Applications
Early identification and monitoring of hearing loss due to ototoxic medication, particularly for cancer patients undergoing chemotherapy with drugs such as cisplatin.
Self-monitoring of hearing health by users at home or in remote locations for clinical and personal audiological care.
Hearing conservation programs and general audiometric hearing threshold testing up to 20 kHz across various settings including hospital wards, outpatient clinics, industrial settings, and homes.
Predictive ototoxicity risk assessment integrating hearing data and drug dosage to guide clinical treatment adjustments.
Objective auditory evoked potential testing for patients unable to provide reliable behavioral hearing responses during treatment.
Use within telemedicine for delivering hearing test results to healthcare providers and facilitating timely intervention.
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