IP Library Granted Patent US 10,582,286
Granted Patent B2
US 10,582,286 · App. 16/450,023 · Granted Mar 3, 2020

Method for treating debilitating hyperacusis

Inventors: David Alan Eddins (Odessa, FL); Charles Craig Formby (Essex, MD); Stephen W. Armstrong (Burlington, CA)
Assignees: University of South Florida; The Board of Trustees of the University of Alabama; SoundsGood Labs, Inc.
H04R1/1016A61F11/08H04R25/505H04R25/75H04R25/502H04R25/558H04R2420/07
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Quick Facts
Patent No.
US 10,582,286
App. No.
16/450,023
Granted
Mar 3, 2020
Kind
B2
Abstract

A system and method of treating hyperacusis is presented. The system uses a customizable, patient-specific, in-ear device combining sound attenuation with loudness suppression and a noise generator to expand the dynamic range of a patient. This device is used with novel software and counseling to provide a patient-specific treatment to hypersensitivity to sound.

Claims (67)

1. A method of diminishing hypersensitivity to sound in a patient in need thereof comprising:

providing a pair of in-ear hearing devices, each comprising:

two interchangeable earmolds wherein one earmold is closed and another earmold is open wherein the earmolds conform substantially to the diameter and geometry of the patient's ear;

a behind the ear shell connected to one of the earmolds by tubing;

a receiver component, a sound generator component, at least one microphone and a signal processing component containing an amplifier all contained within the shell; and

fitting software in electronic communication with the signal processing component, the fitting software configured to execute instructions from the signal processing component to control adjustment of noise generation and loudness suppression compression in the hearing device;

counseling the patient on loudness suppression and the sound generator after providing the in-ear hearing devices;

adjusting loudness compression thresholds based on a patient's frequency-specific loudness discomfort levels after counseling the patient on loudness suppression and the sound generator;

fitting the sound generator to the patient by configuring the sound generator to a set level corresponding to a patient-specific soft loudness judgement after adjusting the loudness compression thresholds; and

systematically increasing the loudness compression thresholds in subsequent sessions with an audiologist to transition the patient to normal hearing.

2. The method of claim 1 , wherein the patient wears both devices as long as can be tolerated in the waking day.

3. The method of claim 1 , wherein the open earmold is swapped for the closed mold and is worn by the patient when in a controlled sound environment where no unexpected sounds are present.

4. The method of claim 1 , wherein the closed mold is worn by the patient when the patient expects to be exposed to an uncontrolled sound environment.

5. A method of treating hyperacusis in a patient in need thereof comprising:

providing a pair of in-ear hearing device, each device comprising:

two interchangeable earmolds wherein one earmold is a closed mold and the other earmold is an open mold which conform substantially to the diameter and geometry of the patient's ear;

tubing connecting one of the two interchangeable earmolds to a behind the ear shell;

a signal processor containing an amplifier, at least one microphone, a receiver, and a sound generator electrically connected and contained within the behind the ear shell;

fitting software in electronic communication with the signal processing component, the fitting software configured to execute instructions from the signal processing component to control adjustment of noise generation and loudness suppression compression in the hearing device;

counseling the patient on the sound generator after providing the in-ear hearing devices;

counseling the patient on the hearing devices after counseling the patient on the sound generator;

connecting the devices to a programming computer after counseling the patient on the hearing devices;

measuring a real ear unaided response (REUR) after connecting the devices to the programming computer;

fitting the hearing devices with the closed molds to each ear of the patient after measuring the REUR comprising:

positioning each hearing device so that the earmold of the hearing device is inserted into one of the patient's ears wherein one ear is a test ear and the other ear is a non-test ear;

estimating a verification noise floor after positioning each hearing device in each of the patient's ears;

measuring real ear occluded response (REOR) by muting the sound generator, amplifier and microphones and administering a broadband or white noise from verification system speakers in the test ear after estimating the verification noise floor;

measuring real ear aided response (REAR) after measuring the REOR;

adjusting a gain-frequency response so that the REAR matches the REUR curve to achieve unity gain and result in real-ear insertion gain (REIG) that is 0 dB across frequency after measuring REAR;

adjusting loudness compression thresholds based on a patient's frequency-specific loudness discomfort levels after adjusting the gain-frequency response; and

repeating above steps for the other device in the non-test ear;

fitting the sound generator to the patient by configuring the sound generator to a set level corresponding to a patient-specific soft loudness judgement after fitting the hearing devices comprising:

inserting the one hearing device into each of the test and non-test ears of the patient;

activating the sound generator of the hearing device in the test ear of the patient to emit a low-level broadband noise after inserting the hearing device;

establishing a level with the patient where the noise is perceived to be comfortable but soft according to the Contour Loudness Test Category 3 after activating the sound generator;

varying loudness of the noise and obtaining categorical loudness judgments on the noise from the patient after establishing the level where the noise is comfortable but soft;

measuring real-ear sound generator (RESG) level to quantify SG output after varying the loudness of the noise and obtaining the categorical loudness judgments from the patient;

repeating above steps for the hearing device in the non-test ear; and

balancing both devices after the above steps are conducted on both the test and non-test ears of the patient; and

systematically increasing the loudness compression thresholds in subsequent sessions with an audiologist to transition the patient to normal hearing.

6. The method of claim 5 , further comprising administering audiometric testing to the patient prior to providing the hearing device to the patient.

7. The method of claim 5 , further comprising muting the receiver and amplifier and the at least one microphone of both hearing devices with the sound generator off prior to inserting the hearing devices into the patient's ears.

8. The method of claim 5 , wherein the sound generator is calibrated after estimating the noise floor by unmuting the sound generator and administering a white noise stimulus in the test ear.

9. The method of claim 5 , further comprising comparing data from REOR, REUR and noise floor to reference data in the fitting software prior to the fitting the sound generator.

10. The method of claim 5 , wherein the REAR is measured by the steps comprising:

muting the sound generator;

unmuting the receiver and amplifier and microphones after muting the sound generator;

administering a broadband or white noise stimulus to the test ear after unmuting the receiver;

having the patient categorize loudness of the stimulus after administering the broadband or white noise; and

subsequently increasing a frequency of the stimulus at intervals until the patient reports loudness category 6 categorical judgment.

11. The method of claim 5 , wherein the patient wears both devices for at least 8 hours per waking day.

12. The method of claim 5 , wherein the open earmold is swapped for the closed mold and is worn by the patient when in a controlled sound environment where no unexpected sounds are present.

13. The method of claim 5 , wherein all measurement stimuli are emitted at frequencies above the noise floor.

14. The method of claim 5 , wherein the both devices are balanced by activating the both devices simultaneously and adjusting each device to have equal loudness.

15. The method of claim 5 , wherein loudness suppression is released about every 4 weeks.

16. The method of claim 5 , wherein the closed mold is worn by the patient when the patient expects to be exposed to an uncontrolled sound environment.

17. A system for use in treatment of hyperacusis in a patent in need thereof comprising:

a hearing device comprising:

two interchangeable earmolds wherein one earmold is a closed mold and the other earmold is an open mold which conform substantially to the diameter and geometry of the patient's ear;

tubing connecting one of the two interchangeable earmolds to a behind the ear shell; and

a signal processor containing an amplifier, at least one microphone, a receiver, and a sound generator electrically connected and contained within the behind the ear shell;

fitting software in electronic communication with the signal processor, the fitting software configured to execute instructions from the signal processor to control adjustment of noise generation and loudness suppression in the hearing device;

verification software in electronic communication with the fitting software wherein the verification software is configured to transmit reference data to an external computing device for comparison with patient data; and

a counseling protocol wherein the counseling protocol provides counseling for both the sound generator and the loudness suppression.

18. The system of claim 17 , wherein the hearing devices are inserted into the patient's ears and loudness compression thresholds are adjusted based on a patient's frequency-specific loudness discomfort levels.

19. The system of claim 18 , wherein the sound generator is fitted to the patient by configuring the sound generator to a set level corresponding to a patient-specific soft loudness judgement.

20. The system of claim 19 , wherein the loudness compression thresholds are systematically increased in subsequent sessions with an audiologist to transition the patient to normal hearing.

Assignments (4)
CONFIRMATORY LICENSE Recorded Aug 7, 2024
From: UNIVERSITY OF SOUTH FLORIDA
To: NATIONAL INSTITUTES OF HEALTH
Reel/Frame 068380/0570 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 23, 2019
From: ARMSTRONG, STEPHEN W.
To: SOUNDSGOOD LABS, INC.
Reel/Frame 050800/0904 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 27, 2019
From: EDDINS, DAVID ALAN
To: UNIVERSITY OF SOUTH FLORIDA
Reel/Frame 050177/0415 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 27, 2019
From: FORMBY, CHARLES CRAIG
To: THE BOARD OF TRUSTEES OF THE UNIVERSITY OF ALABAMA
Reel/Frame 050177/0469 →
Continuity (2)
Provisional Application 62688492 · Jun 22, 2018
Related Publication 20190394551A1 · Dec 26, 2019
Cited By (1)
US 12,598,431