MXPA00001509A - Acoustic fertility monitor and detector - Google Patents

Abstract

The present invention relates to a non-invasive method and device (200) for detecting hormonal changes in humans by monitoring, and detecting changes in psycho-acoustic sensitivity of humans. In particular, the onset of ovulation in a female, preceded by a sudden increase in the level of luteinizing hormone (LH) in the blood stream, is predicted by measuring various psycho-acoustic responses of the female in certain frequency ranges. The measured psycho-acoustic responses include mono-aural and binaural audio interpretation.

Description

MONITOR AND ACOUSTIC FERTILITY DETECTOR REFERENCE WITH RELATED APPLICATION Hereby, applicants claim priority over the provisional patent application filed above with Serial No. 60 / 055,562, filed August 13, 1997, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and device for determining ovulation status and predicting ovulation in women, and particularly to a non-invasive method and devices for determining the onset of hormonal changes. in humans based on the detection of changes in the psycho-acoustic response of the human body to sound. 1. Previous Technique Some physiological changes in humans are preceded by a sudden increase in the level of certain hormones. One such change, the onset of ovulation in women, is preceded by a sudden increase in the level of luteinizing hormone (LH) in the bloodstream. This increase in the concentration of HL, or emergence, begins approximately 36 to 48 hours before ovulation, reaches its peak around 18 hours before ovulation and ends at the time of ovulation. Emergence results primarily in the expulsion of the ovum after the receptors of the ovaries are affected by the increase in the concentration of HL. Increased levels of HL, as well as other accompanying hormonal changes, cause several physiological and psychological changes. The term "psycho-acoustic" is used in the present to refer to these changes, ie changes that do not seem to be related to physical changes in the ear, but seem to be related to the way in which sound is felt by the system central nervous The term "ovulation state" is used herein to refer to the current physiological and psycho-acoustic state of a woman in relation to the time when ovulation will occur. The term "pre-ovulatory" is used to refer to that state of ovulation that exists during the period that begins 36 to 48 hours before ovulation and ends around the time of ovulation. The term "not pre-ovulatory" refers to the period that is outside the pre-ovulatory period. Different methods of indicating changes in a woman's physiological characteristics before and during menstrual cycles are currently used in clinics to determine the onset of ovulation. For example, increases in the concentration of HL in the urine of a woman can be detected during the emergence of HL. Other physiological changes in a woman, such as basal temperature, changes in the secretions of the vaginal mucosa and in the texture of the cervical surface, also occur near the time of ovulation. Dependence on these natural indicators of ovulation is subjective and often requires extensive training to determine them. Moreover, ovulation assays based on urine and blood tests are primarily performed in clinics, although some equipment for home urinalysis is available on the market. Currently, to perform the most reliable ovulation test - measuring the increase in the level of HL - a venous blood test is required. This procedure is expensive, since the blood sample must be processed in a laboratory and the assistance of a specialized clinician is usually necessary. Consequently, due to the delays associated with laboratory tests, the prediction of the fertility window (the 5-day period prior to ovulation) is largely reduced, which, in turn, reduces the likelihood of impregnation. Additionally, the detection of HL emergence in blood or urine often requires multiple trials. Home kits for urine tests are relatively expensive, more than $ 20 per package, and contain only 5 trial bands per team. Additionally, there are other disadvantages associated with home urine testing due to the large number of factors that can alter the accuracy of the assay. Because the blood is filtered, the urine contains high concentrations of HL during preovulatory emergence, and these concentrations can be detected by means of a urinalysis. However, the home urine test is not completely reliable, because the test results are reliable only when performed at certain times of the day. For example, the first urine of the morning can not be analyzed reliably, since the concentration of HL in it is altered, which deflects the results of the trial. Additionally, it can take up to 12 hours after the appearance of HL in the blood for detectable levels of the hormone to concentrate in the urine, thus reducing the window of predictive fertility. Another disadvantage of home urine tests lies in their inability to adjust the scale by specific physiological parameters of an individual. Furthermore, test results are affected by common pharmaceutical or chemical substances such as soap. Finally, the detection of a HL surge usually requires multiple tests, which increases costs. Invasive ovulation detection methods, such as, for example, radioimmune assay, require homogenized blood serum. However, because radioimmune assays measure both beta and HL subunits, they are not completely reliable as indicators of HL. A radio receptor test method measures only the HL-blood serum concentrations and produces more reliable results. However, this test requires either homogenized blood serum or homogenized urine for testing, which decreases the window of predictive fertility due to the delay required for a laboratory analysis. Consequently, due to the number of unreliable factors, conditions and expenses associated with clinical, serum or home urine tests, a more reliable ovulation indicator, easy to operate and that can be used at the convenience of an individual, It will be beneficial for the determination of fertility. It is known that two significant psycho-acoustic changes take place in correlation with a woman's ovulation cycle. It has been documented that the perception of sound within the ear takes place through two different means of audio interpretation, ie interpretation of mono-aural and bi-aural pulses. The mono-aural interpretation takes place when an individual hears a tone with the same frequency in both ears and perceives the vibrations as sound. Normally, an individual can detect sounds in the frequency zone between 20 and 20,000 Hz. Bi-aural audio interpretation occurs when two tones of frequencies differing in 3-6 Hz sound in different ears. Under normal conditions an individual uses a central recapitulation to combine the two tones and perceives the resulting sound as the average of the two different frequencies. This phenomenon produces a howling effect and is perceived in the head as a wandering sound. It has been observed that changes in auditory sensitivity, that is, changes in hearing thresholds, to sounds in certain frequency zones, correlate with the pre-ovulatory state. During the emergence of HL, a woman loses 30-35 dB of hearing and becomes less sensitive or is not able to perceive as many frequencies as she could normally perceive. However, its sound interpretation zone changes, so that the woman is able to interpret a greater number of lower frequency tones, typically tones in the area of around 6,000 Hz to around 14,000 Hz. It has been verified that A change in mono-aural and bi-aural perception takes place in women during the pre-ovulatory period. For exampleJust before ovulation and menstruation, women experience a significant decrease in their ability to measure an absolute tone. In order to be detected by a woman during the beginning of ovulation (the pre-ovulatory state), the volume, or intensity of sounds in the general area of around 6,000 Hz to around 14,000 Hz must be increased by about 10 dB up to about 40 dB over the volume or intensity at which the woman can detect these sounds at other times during her ovulation cycle. Consequently, by detecting and measuring this change in hearing sensitivity, the ovulation status of a woman can be determined and the timing of ovulation can be predicted. The loss of the ability to synthesize bi-aural sounds is another psycho-acoustic change that has been observed as correlated with the pre-ovulatory state. It has been discovered that a woman loses the ability to discern ululating effects within certain frequency zones during the 24-hour period preceding ovulation during the HL cycle. The usual form of bi-aural hearing takes place when two tones differ in about 3 to 6 Hz are presented to the human ear, a tone for each ear. For example, if a 600 Hz tone is presented to one ear and a 603 Hz tone is presented to the other ear, the central nervous system synthesizes a howling tone. The psycho-acoustic phenomenon of bi-aural pulsation synthesis is most noticeable at pulsation frequencies below 1,000 Hz, and the phenomenon is completely unambiguous in the frequency zone of around 400 Hz to 800 Hz. Through the perception of the presence and, subsequently, the loss of this ability to hear a howling sound, the onset of the increase in HL and other accompanying hormonal changes that precede ovulation can be detected, and the probable moment can be predicted. of ovulation. The knowledge of their ovulation status can be used by the woman for birth control purposes, that is, to increase or decrease the probability of conception. There is an old need for an effective, non-invasive procedure, and for means to determine the ovulation status and predict the time of ovulation.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a method and device for detecting the beginning of the pre-ovulation or ovulation stage in a woman by monitoring the auditory sensitivity patterns known as indicative of the Ovulation cycles of women. The monitoring possibilities offered by the present invention offer the user savings in costs, convenience and accuracy. Another object of the present invention is the measurement of the degree of changes in auditory sensitivity to determine the ovulation status and predict the onset of ovulation. It is also an object of this invention to provide a device for detecting and measuring hearing sensitivity thresholds by using different audiometry techniques. In a preferred embodiment of the present invention, a pure simple tone is generated and emitted within the general frequency range of around 6,000 Hz to around 14,000 Hz, with a woman's hearing threshold being detected for this tone . The generation of tones and the measurement of the threshold response of a woman can be effected by the use of known procedures and techniques of audiometry. The threshold value thus obtained is then compared with reference threshold values. The term "reference threshold value" is used herein to refer to any of the following values. The reference threshold values may be one or more values previously obtained from the subject under test. The term "reference threshold value" may also refer to one or more statistically determined values, which represent a typical or average subject in a particular ovulation state. By comparing the current threshold values with the reference threshold values, a significant loss of sensitivity can be detected. In addition, the degree of such loss can be determined and evaluated to determine more precisely the ovulation status of the woman and to predict the time of ovulation.

The preferred method of comparison is a sequential comparison procedure. According to this method, the sensitivity, or threshold response of a subject, is measured at predetermined intervals using standard audiometry techniques. The measurements thus obtained can be recorded in a graphic table, but preferably they are stored in the memory of a computer or microprocessor and used to form the baseline or reference threshold measurements with which the subsequent measurements obtained from the subject are compared. In other words, the most recent threshold value obtained is compared with the previous values so that trends towards increasing or decreasing sensitivity can be detected, future values predicted and current status determined. The well-known statistical mathematical analysis, filtering techniques and computer programs can be used to process the measurements in the way they have been described. When a significant reduction is detected, that is, the reduction is greater than what can be justified by normal fluctuations or measurement errors, it is probably the pre-ovulatory state.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a device for the determination of ovulation status based on the bi-aural pulsation synthesis detection capability according to the principles of the present invention. Figure 2 illustrates a device for determining ovulation status based on the detection of loss of auditory sensitivity in accordance with the principles of the present invention. Figure 3 illustrates a block diagram of a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION Figure 2 illustrates a device 200 for detecting ovulation status by measuring the mono-aural hearing sensitivity. The device 200 comprises a housing 201 within which an audiometric device 211 is housed (not visible in Figure 2)., but illustrated in the diagrammatic form in Figure 3 in 311). This audiometric device 211 comprises well-known audiometric circuits for the measurement of auditory sensitivity in the frequency region that is of interest and which is capable of providing a representative output of the measurements made. In particular, this audiometric device 211 comprises a tone generator, a system of emission circuits that allows the emission of tone or tones with various intensity levels and control circuits. The tone generator is preferably capable of generating pure tones in the frequency range of about 5,000 Hz to about 16,000 Hz. The intensity levels of the emission circuits vary from around 3 dB to around 40 dB. The control circuits cause the tone or tones to be repeated at discrete loudness levels. The audiometric device 211 also comprises a device for signaling 209 and a device 208 for the emission of audible tones. In this preferred embodiment, the signaling device 209 is an on-off switch or button located in the housing 201. However, alternative devices for signaling will be apparent to those skilled in the art. Such devices include, but are not limited to, remote on-off switches and voice-activated on-off switches. Preferred devices for the emission of audible tones 208 is a speaker capable of emitting in the area of frequencies of interest. Alternative devices for the emission of audible tones 208 include hearing aids and headphones or a telephone. The device 200 further includes a display 204 located in the housing 201. In the preferred embodiment, this display 204 shows a representation of the ovulation status of the subject being analyzed. This representation can be numerical, alphanumeric, graphic or pictorial. The present preferred embodiment includes an alphanumeric viewer.

The measurements can be carried out using a pure simple tone in the area of frequencies of interest, or sequentially presenting tones of different frequency in the area. If tones of different frequencies are used, the representation of the sequence can be ascending, descending or mixed. The reduction in sensitivity (or increase in the hearing threshold) can be determined using conventional audiometric procedures, already well known, by using specially designed devices appropriate for a particular application or by any other device for presenting tone in the desired frequency zone at various sound levels. The reduction in auditory sensitivity is determined by device from the repeated comparison of current sensitivity with the sensitivity measured in the area from around 6,000 Hz to around 14,000 Hz during the period preceding the beginning of the increase in the level of HL. When the measurement shows a reduction in auditory sensitivity (or an increase in the hearing threshold) greater than a certain normal measurement error, it is highly probable that the increase in the level of HL preceding ovulation has begun. After having detected this increase in the level of HL, the most probable moment of ovulation can be predicted. In the preferred embodiment, the device 200 is used by holding it close to the ear and pressing and holding the on-off button 209. In this design, the tone generator produces a sequence of four tones as follows: 600 Hz, 8,000 Hz, 10,000 Hz, and 12,000 Hz, each lasting 3 seconds. The intensity of the tones in the sequence is adjusted according to the normal increase in the hearing threshold with an increasing frequency. The 600 Hz tone, which can be easily heard by humans, is a ready tone that also serves to assure the user that the device 200 is working. The control circuits repeat the tone sequence ten times, starting at around 3 decibels and increasing the intensity of the high frequency tones by 3 decibels for each repetition of the sequence. The intensity of the 600 Hz tone remains constant. When the user hears the high frequency tones, the on-off button 209 is released. The device counts the number of times the sequence was repeated until it was heard. This count is displayed as 0-9 in the right window of the LED monitor. The device stores the current count in its memory. The memory also contains the counts of the previous two times the device was used. These are also displayed in the middle and to the right of the LED viewer window. If the count pattern is ascending, it indicates an increase in the hearing threshold for the tones in the presented frequency zone, thus indicating an emergence of HL. Other tone patterns can also be used, as well as the duration and sequences of the presentation of the tones. Figure 1 illustrates a device 10 for the determination of the ovulation state by measuring the bi-aural pulsation synthesis capability performed according to the principles of the present invention. The bi-aural pulsation synthesis capacity can be measured using pure tone pairs in the frequency range of 100 Hz to 1,000 Hz. A first tone of a preset tone pair is presented to a woman's ear, and the second tone of the preselected tone pair is presented to the other ear. Each pure tone of a pair of tones is selected from the frequency range of 100 Hz to 1,000 Hz so that the first tone of the pair differs in frequency from the second tone of the pair by about 1 Hz to about 60 Hz. More than a couple of tones can be presented to a woman. Either the high tone or the low tone of the tone pair can occur either to the right ear or to the left ear. Next, a measurement of the bi-aural pulsation synthesis capacity of the subject is made by using audiometric techniques well known in the art. In accordance with the teachings of the present invention, the measurements thus obtained are compared with the non-pre-ovulatory capacity to synthesize bi-aural pulsations. By detecting and comparing the current capacity with known reference values, the increase in HL can be detected, as well as other hormonal changes that precede ovulation. An indication of the woman's current ovulation status can be obtained and provided to a woman, or to the operator of the device. A prediction of the timing of a woman's ovulation can also be provided. The device 10 comprises a housing 1 within which an audiometric device 11 is housed (not visible in Figure 1, but illustrated diagrammatically in Figure 3 at 311). This audiometric device 11 comprises well-known audiometric circuit systems for the measurement of the bi-aural pulsation synthesis capability in the pulse frequency range of interest, and which is capable of providing a representative output of the measurements made. In the preferred embodiment, the device comprises a tone generator capable of producing pure tones in the frequency range of about 100 Hz to about 1,000 Hz and a set of headphones capable of reproducing the tones generated. The device produces a tone on one frequency and the second tone on another frequency, emitting these tones on the stereo headphones, a pure tone for each headset. The audiometric device 11 also comprises a device for signaling 9 and a device for the emission of audible tones 8. In the present preferred embodiment, the signaling device 9 is an on-off switch or button 9, located in the housing 201. However, other alternative signaling devices will be apparent to those skilled in the art. Such devices include, but are not limited to, remote on-off switches to voice-activated on-off switches. The present preferred device for the emission of audible tones 8 is a stereo headset capable of emitting in the area of frequencies of interest and simultaneously emitting two tones of different frequency to the ears of the user. Alternative devices for the emission of audible tones 8 include other types of headphones, as well as, possibly, a dual speaker arrangement. The device 10 can also include a viewer 4 located in the housing 1. In this viewer 4, a representation of the ovulation status of the person being analyzed can be displayed. This representation can be numerical, alphanumeric, graphic or pictorial. The preferred method of using this device comprises placing the headphones in the ears and pressing and holding the on-off button. If the user experiences the psycho-acoustic phenomenon of bi-aural pulsation, the HL surge or other hormonal changes that precede ovulation have not begun. If the user, who has already experienced the phenomenon before, loses the psycho-acoustic ability to synthesize the bi-aural pulsations, it is highly probable that the onset of HL has begun, as well as other accompanying hormonal changes, and therefore can predict the beginning of ovulation. Any atrial device capable of presenting pure tones stereophonically can be used to determine the presence or absence of the phenomenon of bi-aural pulsation. Figure 3 is a block diagram of a device 310 for determining ovulation status in accordance with the principles of the present invention. The device 310 is the block diagram representation of the devices 10 and 200, and shows the interrelation of the main components of these embodiments. Both the device 10 and the device 200 comprise an audiometric device, as indicated by reference 311. This audiometric device includes a device for signaling 309, and a device 308 for the emission of audible tones to a woman within the area of frequencies of interest. In the case of hearing threshold measurements, the frequency range of interest fluctuates from about 6,000 Hz to about 14,000 Hz. In the case of bi-aural pulsation synthesis capability measurements, the desired frequency range is preferably between about 100 Hz and about 1,000 Hz with a difference in pulse rates between about 1 Hz and 60 Hz. In a preferred embodiment of the present invention, this audiometric device 311 is capable of measuring both the bi-aural pulsation synthesis capacity and the subject addition threshold. The audiometric device 311 includes an output circuit for the emission of the results of the measurements described above. The results of the measurements described above can be provided to a memory 312 and can also be provided to a processor 303. The memory 312 stores the emission of the audiometric device 311, and is also configured to store reference values and measurements. The memory 312 is connected to the processor 303. The processor 303 compares the emission of the audiometric device 311 with the previously obtained reference values and stores them in the memory 312. The processor 303 makes a determination with respect to the ovulation state of the subject under analysis comparing the emission of the audiometric device 311 with the stored reference values. An output of the processor 303 is connected to the display 304, which provides an indication of the ovulation status of the subject under analysis. This indication can be displayed in numerical, alphanumeric, pictorial or graphic form.

In the preferred embodiment of the present invention, the display device 304 allows the presentation of the audiogram output data of the audio meter 311, that is, of the sound level as a function of the frequency corresponding to the hearing threshold. , or the ability of synthesis of bi-aural pulsation of the subject. The ovulation state of the subject can then be determined manually by device of the audiogram comparison thus obtained, with a reference audiogram that has been determined to represent known ovulation states, ie, pre-ovulation, ovulation, post-ovulation, etc. The reference audiogram may be exclusive to the specific subject under analysis, and may be derived from one or more readings previously obtained during the course of the subject's ovulation cycle. Alternatively, the reference diagram may represent typical audiogram values or known prodispositives that correlate with the ovulation cycle for a given number of subjects. However, in the preferred embodiment, the determination of the ovulation state described above is performed automatically by the processor 303. The results of the determination of the ovulation state are emitted by the processor 303 to the display device 304. The Processor 303 can be programmed by conventional devices to implement the general algorithm of: first accepting the output of the audiometric device; then comparing the output output of the audiometric device with the predetermined, pre-stored audiometric values, i.e. a reference audiogram stored in the memory 312; then make a determination regarding the ovulation status based on the comparison; and finally providing the results to the display device 304. The display 304 may have a built-in LED display, an LCD display, or a plurality of digital or similar displays and indicators. The display device 304 may also be an audio indicator that provides digitized, synthesized or recorded voice messages related to the ovulation status. The display device 304 may also provide a graphic representation of the processor 303's output, as in a typical graphics recorder of a type well known in the art. Accordingly, the audiometric device 311 can be a standard audio measuring device purchased in any business. Alternatively, a common audiometric device, which is adapted to conform to the preferably small size, lightweight characteristics, and frequency range of interest, of the device of the present invention may be used.

In communication with the audiometric device 311 is a device 308 for the emission of audible tones to one or the other ear of the subject. The device 308 for the emission of audio tones preferably comprises headphones or stereo headphones. Stereo speakers or hearing aids are currently the preferred means of measuring the bi-aural pulsation synthesis response. However, one or more speakers may be effective as an alternative means of emitting audio tones to the subject, especially for the purpose of measuring the hearing threshold response. The device of the present invention further comprises a signaling device 309, which is also connected to the audiometric device 311. This signaling device 309 can be activated by the subject in response to tones emitted by the device 308 for the emission of tones of audio to a subject so that the subject's hearing threshold can be determined. In a preferred embodiment, this signaling device 309 is an on-off switch, or a button, which is activated by the subject in response to the presentation of audio tones. The alternative signaling device 309 may include an audio input circuit that responds to speech signals from the subject. Other signaling devices will be apparent to those skilled in the art, and fall within the scope of the present invention. It is also contemplated within the scope of the present invention that the storage, comparison, display and processing of data, such as, for example, magnitudes of sound intensity, signals, measured responses and other data, can be performed by a computer. It is understood that the description given above of the preferred embodiment embodiments of the structure of the present invention, as well as the description of its operation are only one or two of the best preferred embodiments for implementing the invention. Other modifications and variants may be conceived by those skilled in the art after reading the preferred embodiments and after a consideration of the specification. These modifications and variations are, however, within the scope of the specification of the present invention.

Claims (38)

1. Procedure for detecting changes in the psycho-acoustic sensitivity of a user caused by changes in the hormonal concentration in the user, characterized in that said procedure comprises the steps of: generating a sequence of tones, said sequence comprising tones of different frequencies; providing a number of sequences of different sound intensities to the user, receiving from the user a signal indicating the current magnitude of the sound intensity of the sequence to which the user listens to the sequence; and using the signal of the user indicative of a change in the psycho-acoustic sensitivity of the user, to detect a change in the hormonal concentration of the user.

Method according to claim 1, characterized in that it also comprises the storage of the magnitudes of sound intensity and the observation of differences between the current magnitude of sound intensity and the magnitude of the pre-stored sound intensity, the difference being indicative of a change in the psycho-acoustic sensitivity of the corresponding user with a change in hormonal concentration.

3. The method according to claim 2, characterized in that it also comprises in a viewer representing a visual indication corresponding to the current magnitude of the sound intensity of the sequence, as well as representing in the viewer a previous visual indication corresponding to a pre-stored sound intensity magnitude. .

4. Method according to claim 1, characterized in that the sequence comprises a tone.

Method according to claim 1, characterized in that it also comprises the storage of the current magnitude of the sound intensity in a memory.

Method according to claim 1, characterized in that the signal of the user is generated by the operation of an on-off button.

Method according to claim 1, characterized in that the sound intensity of a successive sequence provided to the user is greater than the sound intensity of a previous sequence.

8. Method according to claim 1, characterized in that the psycho-acoustic sensitivity is a mono-aural audio sensitivity.

9. The method according to claim 1, characterized in that the change in the hormonal concentration is the change in luteinizing hormone concentration.

10. Procedure for detecting a change in the psycho-acoustic sensitivity of a user caused by a change in the hormonal concentration of the user, characterized in that it comprises the steps of: generating a first and a second tone of different frequencies; provide the tones to the user so that one ear of the user receives the second tone; receive a signal from the user that indicates a change in the user's ability to synthesize bi-aural pulsations; and use the signal to determine the presence or absence of change in psycho-acoustic sensitivity that corresponds to a change in hormonal concentration.

The method according to claim 10, characterized in that the different frequencies of the first and the second tone are below about 1,000 Hz.

Method according to claim 10, characterized in that the psycho-acoustic sensitivity is a bi-aural audio sensitivity.

The method according to claim 10, characterized in that the frequencies of the first and the second tone differ by about 3 to about 6 Hz.

14. Method according to claim 10, characterized in that the psycho-acoustic sensitivity is a bi-aural hearing sensitivity.

15. The method according to claim 10, characterized in that the change in the hormonal concentration is the change in luteinizing hormone concentration.

16. Procedure for detecting changes in the psycho-acoustic sensitivity of a user caused by a change in the hormonal concentration of the user, characterized in that it comprises the steps of: generating an audio output signal with predetermined characteristics; applying said audio output signal to the user, - detecting a change in the user's hearing capacity; and use the results of the detection to determine changes in the hormonal concentration of the user.

Method according to claim 16, characterized in that the detection step comprises the measurement of the user's hearing threshold with the audio output signal.

The method according to claim 17, characterized in that it further comprises the comparison of the detected hearing threshold with a reference threshold.

The method according to claim 18, characterized in that the reference threshold comprises one or more reference threshold values obtained from the user. •twenty.

The method according to claim 18, characterized in that the reference threshold comprises one or more reference threshold values determined statistically to represent a typical user device in a particular hormonal state.

The method according to claim 18, characterized in that the comparison step is used to detect changes in the user's hearing sensitivity.

22. The method according to claim 21, characterized in that it includes the determination of the degree of change in the auditory sensitivity to determine the hormonal status of the user.

Method according to claim 18, characterized in that the comparison stage is carried out sequentially.

Method according to claim 17, characterized in that the threshold of hearing of the user is measured at predetermined intervals to provide a series of measurements, which are used to form a baseline or reference threshold measurements with which they can be compared the subsequent measurements of the user.

25. The method according to claim 24, characterized in that it further comprises using an indication of a predetermined reduction in the user's hearing sensitivity to predict changes in hormone concentration.

26. Method according to claim 16, characterized in that the detection step comprises determining the user's ability to synthesize bi-aural pulsations.

27. Device for detecting changes in the psycho-acoustic sensitivity of a user, caused by a change in the hormonal concentration of the user, characterized in that said device comprises: an audiometric device for obtaining a measurement of the psychosocial response current acoustics of the user and to provide a representative output of said measurement; a device operatively connected to the audiometric device for the storage of the current measurement and for the storage of reference psycho-acoustic response values; a device operatively connected to the audiometric device and to the storage device, for comparison of the current measurement with the reference psychoacoustic response values, so that the hormonal status of the user can be determined, including said comparison device an output of signals representative of the hormonal status of the user; a device connected to the comparison device, for the use of the output signals that allow the determination of the hormonal status of the user.

28. Device for detecting changes in the bi-aural pulsation synthesis capacity of a user, caused by a change in the user's hormonal concentration, characterized in that it comprises: a device for generating first and second pure audio tones, each in one frequency range from about 100 Hz to around 10,000 Hz, and that the first tone differs in frequency from the second tone by about 1 Hz to about 60 Hz; a device for emitting said first and second audio tones simultaneously to the user's ears; a signaling device that can be operated by the user to provide a signal when the user has lost the psycho-acoustic ability to synthesize bi-aural pulsations; and a device operatively connected to the signaling device for the use of the signals to provide an indication of changes in the hormonal concentration of the user.

29. Device according to claim 28, characterized in that the device for the use of the signal includes a device for comparing the user's current measured pulse synthesis capacity with capacity reference values representing the pulse synthesis in several stages of the change of hormonal concentration to provide an indication of the current hormonal concentration of the user.

30. Method according to claim 1, characterized in that the tone sequence is generated in a frequency range from about 6,000 Hz to around 14,000 Hz.

31. Method according to claim 11, characterized in that the first and second tones are propagated at frequencies between about 400 Hz to around 800 Hz.

32. Method according to claim 3, characterized in that at least one stage is performed by a computer.

33. Method according to claim 1, characterized in that the provision stage uses a telephone, an earphone or hearing aids.

34. The method according to claim 10, characterized in that at least one step is performed by a computer.

35. Method according to claim 22, characterized in that at least one stage is performed by a computer.

36. Method according to claim 16, characterized in that the application stage uses a telephone, a headset or hearing aids.

37. Method according to claim 27, characterized in that the audiometric device, the storage device, the comparison device or the device for use include a computer.

38. Device according to claim 28, characterized in that the generating device, the transmission device, the signaling device or the device for use include a computer.