Systems and methods for the screening and monitoring of inner ear function

Inventors

Fausti, StephenEllingson, RogerHelt, WendyJacobs, PeterSilaski, GraysonWilmington, DebraGordon, SamuelDille, MarilynMcMillan, GarnettReavis, KellyMartin, Dawn

Assignees

US Department of Veterans Affairs

Publication Number

US-9480418-B2

Publication Date

2016-11-01

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 systems and methods for monitoring and testing inner ear function, particularly hearing, using a portable unit capable of presenting multiple test frequencies to a user, receiving user responses to auditory stimuli at those frequencies, storing data about these interactions, and comparing this data to previously acquired hearing data. Using mathematical prediction algorithms, the system can identify changes in baseline hearing values to detect potential hearing issues, with a particular focus on those associated with ototoxicity.

The problem addressed arises from the limitations of current audiometric testing equipment which typically requires patients to visit a specialized clinic and be tested in a sound-attenuated room. Such requirements are impractical for patients undergoing treatments such as cancer therapy, who may be severely ill, fatigued, or living in locations far from testing facilities. Early identification and monitoring of hearing loss due to ototoxicity, noise exposure, or other factors are desired but not widely implemented due to these logistics and equipment constraints.

The invention aims to overcome these limitations by providing a portable, precise audiometric system that can operate automatically or manually with pure-tone stimulus generation up to 20 kHz, supporting remote transfer of health status information. The system incorporates personalized testing protocols such as the Sensitive Range for Ototoxicity (SRO), which targets individualized sets of test frequencies critical for detecting early hearing changes efficiently and reliably.

Claims Coverage

The patent includes one independent claim detailing the features of a hearing monitoring system designed for serial hearing loss detection.

Portable hearing monitoring with frequency and stimulus level control

A hearing monitoring system including an audio test unit configured to output test sounds at multiple frequencies and stimulus levels to a user's ear, enabling flexible test administration during multiple tests.

Control system for user frequency selection and response recording

A hearing test control system displaying multiple test frequencies for user selection, triggering audio outputs at selected frequencies and stimulus levels, recording whether the sounds were heard, and storing associated stimulus levels.

Baseline and sensitive range storage and comparison

Storing the highest set of test frequencies heard (the sensitive range for ototoxicity) with baseline stimulus levels, and comparing baseline values with subsequent hearing test data to detect changes.

Change indication and display for hearing status

Displaying on a screen any differences observed between baseline hearing values and current testing results across the sensitive range for ototoxicity, facilitating user and clinician awareness of hearing changes.

The claims define a portable audiometric monitoring system that enables precise frequency and stimulus level testing, personalized identification of sensitive frequency ranges for hearing loss, and comparison of serial test data with baseline measurements for early detection of changes, with display and communication capabilities.

Stated Advantages

Enables early detection and monitoring of ototoxicity-induced and other sensorineural hearing loss in patients who may not travel to specialized clinics.

Supports personalized and time-efficient testing protocols such as the Sensitive Range for Ototoxicity (SRO), reducing test duration and patient burden.

Allows use in remote or mobile settings including patient homes, hospital wards, and industrial environments, improving access to audiometric monitoring.

Integrates ambient noise measurement and active noise cancellation, supporting reliable hearing threshold testing outside sound-attenuated environments.

Includes telemedicine capabilities that enable remote data transfer to healthcare professionals for timely evaluation and intervention.

Provides accurate and repeatable measurements comparable to clinical audiometers, supporting both manual and automated testing modes.

Documented Applications

Early detection and monitoring of ototoxic-induced hearing loss in patients undergoing treatment with ototoxic medications, such as chemotherapeutics like cisplatin.

Self-administered hearing assessment by patients at home or bedside, reducing the need for patient transport to clinics.

Monitoring for hearing changes due to noise exposure or traumatic brain injury.

General audiometric hearing threshold testing across the full frequency range of human hearing (125 Hz to 20 kHz), including high-frequency and ultra-high frequency audiometry in various clinical and non-clinical settings.

Telemedicine applications enabling real-time reporting of hearing status to remote healthcare providers for intervention and management decisions.

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