Acoustics – Anatomic or prosthetic relation – Ear and mouth
Reexamination Certificate
1999-09-14
2002-05-14
Nappi, Robert E. (Department: 2837)
Acoustics
Anatomic or prosthetic relation
Ear and mouth
C181S130000, C181S135000
Reexamination Certificate
active
06386314
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to earphones which cover the ear, and more particularly to earphones for infants for use in hearing screening tests.
BACKGROUND OF THE INVENTION
It is known to conduct tests to identify hearing impairments in humans (also known as “hearing screening”). It is critical and advantageous to determine whether or not any hearing impairments exist at an early age, such as in newborns and infants. This is because the earlier a problem is diagnosed and therapy undertaken, the more likely the therapy or other intervention will minimize the potential problems and costs associated with the identified hearing impairments or loss.
Over the years, hearing screening techniques have been developed which inject a sound input into the ear and detect a response to that input. The response is related to the characteristics of the sound input, the conditions inside the ear, the vibration transmission mechanism of the ear and the neural pathway through to the brain. The response can be analyzed to assess the hearing of the patient.
In many cases, and in particular in the case of infants, hearing screening is performed by using an earphone having a cavity that fits closely about the ear. Auditory tones or “clicks” are fed into the earphone cavity, and the response generated by the patient's ear and the neural activity system in response to the auditory tones is sensed by a transducer. The transducer may be, for example, a microphone, suitable electrodes, an electroencephalogram (used in auditory brainstem response tests), piezo electric materials and like devices that read signals representative of the response to the auditory input. These signals are then processed and the result (as well as the detected signals, if desired) can be displayed on a monitor or other viewing device for analysis of the patient's hearing.
A common problem using this method is that ambient noises are capable of interfering with the stimulus or the response signals, and, thus, the result. In most cases, the monitoring equipment has mechanisms, such as microphones, for detecting and compensating for ambient background noise. However, compensating for noise inside the cavity is difficult. This difficulty is compounded when the earphones do not adhere fully to the skin surface of the patient's head. Any “pulling away” from the head can create a gap which, in turn, may result in “leakage” of acoustic energy. Such leakage may effect any testing. Further, the earphone must be precisely placed on the head of the patient such that the cavity is centered over the ear or the measured response may not be accurate.
Another concern when testing the hearing of children is the delivery of the acoustic energy. Damage to the ear can result if too much acoustic energy is delivered. Typically, the transducers commonly employed to deliver this acoustic energy are designed to work in combination with the earphone assembly and deliver a controlled amount of acoustic energy. However, when earphones are used in combination with other transducers, the resultant acoustic energy is less certain and thus may be too high, causing damage to the ear.
U.S. Pat. No. 4,930,520 to Liverani, incorporated herein by reference, provides a disposable earphone for testing the hearing in infants which includes a toroidal baffle of anechoic, insulative foam, a rigid clear planar window plastic sheet adhered to one side of the baffle defining a cavity, and an adhesive coating on the other side of the baffle for temporarily bonding the disposable earphone to the region surrounding the infant's ear. The earphone is capable of being used with transducers for transferring acoustical energy to the infant's ear for testing. The Liverani device has been commercialized and is sold under the trademark EAR COUPLERS® disposable earphones by Natus Medical Incorporated, the assignee of this invention.
U.S. Pat. No. 5,826,582 to Sheehan et. al., incorporated herein by reference, relates to an earphone assembly for use with a hearing screener particularly suitable to test infants for hearing impairment. The earphone includes a generally D-shaped reusable cover formed of a rigid material. The cover has a back wall, a side wall extending from the perimeter of the back wall to define a cavity, a port in the cover to receive a transducer, and a generally D-shaped disposable element that is adhesively coated on two sides to be secured to the cover and to the patient's head. The cover may have a notch located along the perimeter of the re-usable body for removing the disposable element. A liner is used to cover the disposable element adhesive sides to protect them from contamination during packaging and prior to use. The disposable element may have a die cut so that a portion of it can be removed to make the earphones adjustable for infants with large ears.
One difficulty with existing earphone assemblies is that the baffles or covers must deform to match the contour of the patient's head. In particular, near the jaw, the patient's head is naturally contoured and does not present a flat mating surface for the earphones. When using a compressible, elastic material for the baffle, internal shear stresses are created between adjacent portions of the baffle since these portions will be compressed or stretched different amounts. As the material seeks to return to its original shape, certain portions of the baffle may be pulled off the patient's head, creating a “leak” for acoustic energy. This problem is exacerbated by the rigid plates employed as lids that transfer the pull to the baffle material. While earphones can be formed to match the contour of a particular patient's head, this may be inordinately expensive and may require custom earphones for each patient and earphones designed specifically for either the left or right ear.
Thus, although the aforementioned prior art devices are useful in hearing screening there remains a need for an improved earphone that overcomes the inadequacies of the known devices and, further, provides advances that improves the attenuation of ambient and external noise inside the cavity of the earphone. In particular, an inexpensive device for readily and accurately matching the head contour without resulting in a substantial loss in acoustic energy during testing is required.
OBJECTS AND SUMMARY OF THE INVENTION
Accordingly, it is an advantage of an aspect of the instant invention to provide an earphone assembly capable of flexing to better match the contours of the patient's head.
It is an advantage of another aspect of the invention to provide an earphone assembly that is capable of being used with ears of different sizes and for either the left or the right ear.
It is an advantage of another aspect of the invention to provide an earphone assembly that is generally insulated from external noise.
It is yet an advantage of another aspect of the invention to provide an earphone assembly that includes a visual grid or target to assist caregivers in positioning the earphone about the ear during hearing screening tests.
It is an advantage of yet another aspect of the invention to provide an earphone assembly that includes a flexible lid cooperating with a flexible baffle to fit snugly on the heads of patients of various sizes.
It is an advantage of yet another aspect of the invention to provide an earphone assembly with an increased adhesive area for better securement to a patient's head.
It is an advantage of yet another aspect of the instant invention to provide an earphone assembly that is flexible and yet inexpensive to manufacture.
It is an advantage of yet another aspect of the instant invention to provide an earphone assembly that delivers consistent acoustic energy during a hearing test.
In accord with one aspect of the invention, an earphone is provided that includes an annular baffle having an outer surface and an inner surface separated by a height as well as an interior wall and an exterior wall separated by a thickness. The inte
New, Jr. William
Sheehan Neil J.
Sheraton David
Wakayama Toshibumi
Walton Christian
Lockett Kim
Nappi Robert E.
Natus Medical Inc.
Orrick Herrington & Sutcliffe LLP
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