background image

- 23 -

IMPORTANT NOTICE FOR 

PROSPECTIVE HEARING AID USERS (cont’d):

Medical Evaluation Requirements - Federal law requires that 

every  prospective  user,  prior  to  being  fit  with  hearing  aids, 

must  have  their  hearing  tested  by  a  hearing  professional.   

Hearing aid dispenser shall not sell a hearing aid unless the 

prospective user has presented to the hearing aid dispenser 

a written statement signed by a licensed physician that states 

the patient’s hearing loss has been medically evaluated and 

the patient may be considered a candidate for a hearing aid. 

The  medical  evaluation  must  have  taken  place  within  the 

preceding 6 months.

Alternatively, Federal law allows for a fully informed 

individual to sign a written waiver of the medical evaluation 

provided all of the following conditions are met:

(i) The prospective user must be aged 18 or above.

(ii) The prospective user are informed of the exercise of the 

waiver of medical evaluation is not in their best health interest.

(iii) The prospective user is not in any way actively encouraged 

to waive such a medical evaluation.

(iv) The prospective user is provided a copy of the User 

Instructional Brochure detailed with the name and address of 

the manufacturer or distributor from whom the User 

Instructional  Brochure  is  obtained;  in  that  the  prospective 

user has the opportunity to review and read the content of 

the User Instructional Brochure.

(v) The prospective user is to sign the Statement of Waiving 

Medical Evaluation that provided on the follwoing page for 

the prospective user to complete.

Summary of Contents for NeoMatic IIe

Page 1: ...NeoMatic ProsonicIIe HearingSoundAmplifiers BatteryOperated I N S T R U C T I O N S M A N U A L ...

Page 2: ......

Page 3: ...epair service 16 Use and care 17 Limited Warranty 18 Statement of using hearing aids 19 Identification of known side effects 19 Warning to hearing aid dispensers 20 Important notice for prospective hearing aid user 21 Medical Evaluation Requirements 23 Statement of Waiving Medical Evaluation 24 Product technical information 26 Manufacturer distributor information 28 ...

Page 4: ...User s Instructional Brochure before using the ProSonic IIe Hearing Sound Amplifier All of the operating instructions in this brochure should be followed when using the device Please read and observe the warning statements and be sure to keep this instructional brochure for future reference Note Extra copies of this User s Instructional Brochure are made available to any hearing aid professional u...

Page 5: ...ic IIe Hearing Sound Amplifier consists of one ProSonice IIe sound amplification unit one flex ear hook three silicone flange ear tips two AG13 LR 44 1 5 volt Alkaline button cell batteries as illustrated below 3 ...

Page 6: ...page indicating the function of all controls intended for user adjustment and the location of the battery compartment convenient to you in using the device ProSonic IIe side view right diagram 4 ON OFF and High Low Switches LED Indicator Lamp Silicone flange eartip Flex Ear Hook Microphone ...

Page 7: ...ProSonic IIe side view left diagram 5 Volume Control Flex Ear Hook Pivot Battery door Silicone flange eartip Receiver end speaker ...

Page 8: ...e are in the low profile flange design providing additional hold in the ear to keep the device from falling off More importantly the silicone flange ear tips helps stop feedbacks that generated by the sound amplification unit travelling into the ear 2 Place one of the three silicone flange ear tips onto the receiver end of the device holding the device with your left hand twist to push gently the ...

Page 9: ...he battery polarity must be correctly observed when inserting battery cells onto the battery compartment The steps below are to guide you through in installing or replacing batteries for your ProSonic IIe Hearing Sound Amplifier 1 Diagram on your left shows the battery compartment cover of the device Place securely the device in between your index middle fingers of your left hand slightly push the...

Page 10: ...install two AG13 LR 44 battery cells that supplied to you Be sure the positive post flat end of each battery you installed is facing you see diagram below 3 To return the battery compartment cover to the device place the back end of the cove first then snap close See diagram next page 8 1 2 3 4 ...

Page 11: ... in use For optimal performance replacing batteries in the device on a regular basis is recommended Though the device is designed to operate on 2 pieces of the AG13 LR 44 1 5V Alkaline battery cells you have the option to use 675D zinc air hearing aid batteries as an alternative power source The 675D zinc air hearing aid batteries may provide longer battery life per se Caution If you accidentally ...

Page 12: ...e to either Low or Hi position The red LED light will light indicating the device in its ON operating state Hi is for listening to high pitch sound e g music Low is for listening to low pitch sound e g conversations The device may be operated all time in either Hi or Low position that would best suit your needs 10 ...

Page 13: ... side of the device Turn the knob with your thumb or index finger for adjusting volume up down Slowly turning the knob to your left to increase sound volume and to your right to decrease See diagram below 4 For best results we suggest starting in Low position with the volume control on low gradually increase volume to your preference Do not set the volume too high High volume may cause excessive f...

Page 14: ...earing the ProSonic IIe in your LEFT ear hold securely the device between the thumb and index finger of your LEFT hand with its bottom the side where the ear tip is located facing you place into your LEFT ear the ProSonic IIe with an ear tip installed use the thumb and index fingers of your RIGHT hand adjusting the Flex Ear Hook to rest behind your LEFT ear 2 While wearing adjust the Flex Ear Hook...

Page 15: ...justing the Flex Ear Hook to fit your RIGHT ear a Setup of the device below in the diagram on your left is for fitting your LEFT ear Now rotate counterclockwise the device on its pivot with the spear tip pointing to your RIGHT 13 Spear tip pointing right Spear tip pointing left ...

Page 16: ...er and thumb of your LEFT hand on the midway of the flex wire pull it straight up from the device See diagram below c Use the index finger and thumb of your LEFT hand with the help of your RIGHT hand bend the flex wire with its tail pointing downwards towards your LEFT to form an alternative Ear Hook for wearing on your right ear 14 ...

Page 17: ...ASE OF FEEDBACK OCCURRED Issue of feedback is created by the noise produced from the device speaker travelling to the back of the amplifier In order to remove feedback you should fit the device properly into your ear by adjusting its ear tip to leave no gaps for feedback travelling between your ear and the ProSonic IIe Hearing Sound Amplifier To appropriately tune sound volume is always helpful to...

Page 18: ...cleared of debris and dirt 3 Wipe the case with damp cloth only Do not use liquid or aerosol cleaners to clean the device 4 When you are not using your ProSonic IIe Hearing Sound Amplifier take the batteries out of the device and store it in a dry cool place keep out of reach of children REPAIR SERVICE For repair service you should feel free to contact the repair service center directly for asista...

Page 19: ...nd Amplifier in a hot and humid environment the device can be sensitive to excessive heat and moisture Never attempt to take the ProSonic IIe Hearing Sound Amplifier apart or trying to fix it by yourselves If there are problems with the device return it to the Customer Service Center for repair or exchange When not in use the ProSonic IIe Hearing Sound Amplifier should be stored in a box that is d...

Page 20: ...upon return of the defective device You should however be responsible to send the defective device to us on paid shipping We offer NO WARRANTY in case of wear and tear from daily use inadequate care maintenance failure to follow instructions that outlined in this manual battery installed improperly exposed the device to water fluids or used in an excessive hot and humid environment misuse the devi...

Page 21: ... from it The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip reading IDENTIFICATION OF KNOWN SIDE EFFECTS There can be side effects associated with the use of a hearing aid that may warrant consultation with a physician such as accelerated accumulation of cerumen ear wax skin irritation or headaches Stop wearing ...

Page 22: ...user has any of the following conditions 1 Visible congenital or traumatic deformity of the ear 2 History of active drainage from the ear within the previous 90 days 3 History of sudden or rapidly progressive hearing loss within the previous 90 days 4 Acute or chronic dizziness 5 Unilateral hearing loss of sudden or recent onset within the previous 90 days 6 Audiometric air bone gap equal to or gr...

Page 23: ...sts otologists or otorhinolaryngolgists The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased Following the medical evaluation the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidat...

Page 24: ...ed physician Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician The exercise of such a waiver is not in your best health interest and its use is strongly discouraged CHILDREN WITH HEARING LOSS In addition to seeing a physician for a medical evaluation a child with a hea...

Page 25: ...y informed individual to sign a written waiver of the medical evaluation provided all of the following conditions are met i The prospective user must be aged 18 or above ii The prospective user are informed of the exercise of the waiver of medical evaluation is not in their best health interest iii The prospective user is not in any way actively encouraged to waive such a medical evaluation iv The...

Page 26: ...ed if I had a medical evaluation by a licensed physician preferably a physician who specializes in diseases of the ear before purchasing a hearing aid I do not wish a medical evaluation before purchasing a hearing aid Waiver signature ______________________ Date signed __________________________ The prospective user is required to mail a signed copy of the Statement of Waiving Medical Evaluation t...

Page 27: ...ar sound they are both wearable and some of the technology and function is similar However the products are different in that only hearing aids are intended to make up for impaired hearing Consumers should buy a personal sound amplifier only after ruling out hearing loss as a reason for getting a hearing aid If you suspect hearing loss get your hearing evaluated by a health care professional Treat...

Page 28: ... AG13 LR 44 alkaline cells 3 0V 3 0V Battery current drain 5 1mA 5 1mA Equivalent input noise 43dB 47dB Frequency range 200 3500Hz 200 3200Hz Frequency response curve charts shown on next page 93dB 1KHz 93dB 1KHz Saturation output curve SSPL90 133dB 800Hz 134dB 800Hz Average saturation output HF average full on gain 119dB 117dB Reference test gain 29dB 27dB Total harmonic distortion 3 500Hz 3 500H...

Page 29: ...ithmic scale representing these units in a manageable way The performance specifications of your ProSonic IIe Hearing Sound Amplifier is measured in dBSPL The citation test data for the ProSonic IIe Hearing Sound Amplifiers on the earlier page and the frequency response curve charts in the above of this page are obtained on testing of the device against the ANSIS3 22 2003standardwhichisincomplianc...

Page 30: ...ATIONAL LTD Room 1403 Fook Yip Building 53 57 Kwai Fung Crescent Kwai Chung New Territories Hong Kong Phone 852 2619 0833 Fax 852 2429 0960 Email info wellbrain intl net FDA registration number 3004950644 FDA owner operator number 9032154 The ProSonic IIe Hearing Sound Amplifiers are imported and or distributed to in the United States by 28 ...

Page 31: ......

Page 32: ...ontinuous product development photos and graphics for illustration purpose in this User s Instructional Brochure may slightly vary from the actual device delivered Well Brain International Ltd all rights reserved PP0125E ...

Reviews: