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FDA STATEMENTS

Warning to hearing aid dispensers

A hearing aid dispenser should advise a prospective hear-

ing aid user to consult promptly with a licensed physician 

(preferably an ear specialist) before dispensing a hearing 

aid if the hearing aid dispenser determines through inquiry, 

actual observation, or review of any other available 

information concerning the prospective user, that the 

prospective user has any of the following conditions:
• Visible congenital or traumatic deformity of the ear.
•  History of active drainage from the ear within the previous 

90 days.

•  History of sudden or rapidly progressive hearing loss 

within the previous 90 days.

• Acute or chronic dizziness.
•  Unilateral hearing loss of sudden or recent onset within 

the previous 90 days.

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Summary of Contents for Elite Fit

Page 1: ...Elite Fit ...

Page 2: ...ere are a few tips to help you get the most benefits from your OVATION hearing product If you have never worn a hearing aid before there may be an adjustment period of up to a few weeks before you can begin to enjoy all the benefits that OVATION offers Be patient as you adjust to wearing your OVATION and begin hearing sounds that you previously had been missing We recommend that you start by only ...

Page 3: ...periment with the 4 different hearing settings to find the best option for you in different listening environments In all environments but especially in noisy ones you may find it helpful to face the individual speaking to you or to sit or stand near the source of the sound Thank you again for choosing OVATION Please read the following instructions to better understand how to use your OVATION Elit...

Page 4: ...s also serves as the On Off switch Close the door to turn on your device Open the door to turn off the device Ear tube tip each unit comes equipped with an ear tube tip that connects to the unit s speaker Amplified sound travels through the ear tube tip to your ear Retention loop helps keep the ear tube tip in place 3 ...

Page 5: ...Ear Tube Battery Door Ear Tip Retention Loop removable Program Select Button 4 ...

Page 6: ...them unusable in your OVATION Elite Fit Pulling off the plastic sticker activates the battery Do not pull the tab off until you need to use the battery The batter ies may take up 2 minutes to full air activate after the tab is removed With proper use and care each battery should last about 1 week Note A warning of a periodic single beep indicates that the battery needs to be replaced Rounded Edge ...

Page 7: ...THE BATTERY Step 1 Using your fingernail gently pull up on the battery door tab until the door swings open Note Do not push against the volume button and do not open the battery door too far or damage may occur 6 ...

Page 8: ...he battery with the rounded edge positioned toward the back place the battery into the battery compartment Note The rounded side of the battery is negative and the completely flat side is positive The flat side needs to be on the side of the door with the sign 7 ...

Page 9: ... installed close the battery door to turn the device on To turn off the device and to prevent battery use when not using the device gently pull the battery door open 8 Match flat side of battery door with sign on battery door ...

Page 10: ... battery but also serves as the On Off switch ON Simply close the battery door OFF Open the battery door when you are not wearing your OVATION Elite Fit to turn the unit off and conserve battery life Opening the battery door also allows internal moisture to evaporate which keeps the OVATION electronics working well 9 ...

Page 11: ...or the right ear Next place your OVATION Elite Fit over the top of your ear until it rests securely behind your ear While holding your OVATION Elite Fit in place insert the ear tip into the ear canal and curl tuck the retention loop along the body of your ear Note You may find it helpful to use a mirror the first few times you are placing or removing your OVATION Elite Fit ...

Page 12: ...very three months Removing ear tube tip from unit Grasp the device end of the ear tube gently turn 90 degrees and pull to remove the ear tube from the unit Attaching ear tube tip to unit Gently push the device end of the ear tube onto the unit until it snaps into position 11 Turn 90 degrees Pull the device end of ear tube ...

Page 13: ...ire through the ear tube starting at the device end until it comes out at the ear tip end then pull the clean ing wire all the way through Be sure to wipe off the wire before the next cleaning Clean the ear tip with a dry cloth Note Ensure the wire goes through the ear tube in only one direction from device end to ear tip end Do not reverse the wire back through the ear tube 12 ...

Page 14: ... allow you to comfortably hear the sounds you want to hear Note Spend time using each program and volume setting to determine which one you like best Use that setting the majority of the time Simply press and hold the push button for two seconds to change the program setting The OVATION unit will beep to let you know which setting has been selected Note Each time the battery door is opened or the ...

Page 15: ...Settings for Pre Programmed Hearing Aids Settings for Custom Programmed Hearing Aids audiogram Basic amplification Restaurant Party Television Noisy environment 14 ...

Page 16: ... is clean and clear of wax and ear tube is attached properly Microphone and hearing port is clean and clear of wax Battery may need replacing Note Leaving the battery on in your unit overnight will short en battery life exposing your unit to dampness by storing it in the bathroom or other areas with high humid ity can also shorten battery life and eventually damage the instrument 15 ...

Page 17: ...16 Single periodic beep Clean replace ear tube tip Clean replace ear tube tip Check for tears in ear tupe tip ...

Page 18: ...lly remove any traces of wax and debris Do not rinse or submerge your OVATION in water In fact do not not use water alcohol or any other liquid agent to clean your unit as they may damage it If your device does become wet do not use an external heat source to dry it Rather open the batter door remove the battery and let the device dry naturally for 24 hours Remove your OVATION before using hair sp...

Page 19: ...t remove the unit by pulling on the battery door and never pull the door back father than what is necessary to insert or remove a battery When you re not wearing your OVATION Elite Fit open the battery door to save on battery life and to allow any internal moisture to evaporate Store your unit in a safe dry place that is away from direct sunlight and extreme temperatures 18 ...

Page 20: ...oes not cover malfunctions due to unusual wear and tear or mistreatment of the hearing aid such as physical shock damage from moisture or sweat excessive wax build up or tampering with the instrument all of which void the warranty If you require warranty service please contact customer service at support ovationhearing com If the unit requires repair after 1 year you may contact us at support ovat...

Page 21: ... return it and we will issue a full refund no questions asked To initiate a return call us within 60 days of receiving your order to obtain a Return Merchandise Authorization RMA All returns must include an RMA All warranty service and product returns should be directed to OVATION Hearing 1409 Fairfield Road S Suite 101 Minnetonka MN 55305 20 ...

Page 22: ...dB SPL Average full on gain 109 dB SPL Peak gain 40 dB Reference test gain 30 dB Frequency range 200 5500 Hz Total harmonic distortion 3 Equivalent input noise 32 dB SPL Battery current drain 9 mA Induction coil sensitivity n a Attack 6 mS Release 30 mS 21 ...

Page 23: ...22 ANSI FR Curve 60dB input OSPL90 Curve ANSI FR Curve 60dB input OSPL90 Curve f 2000 Hz ...

Page 24: ...inquiry actual observation or review of any other available information concerning the prospective user that the prospective user has any of the following conditions Visible congenital or traumatic deformity of the ear History of active drainage from the ear within the previous 90 days History of sudden or rapidly progressive hearing loss within the previous 90 days Acute or chronic dizziness Unil...

Page 25: ...ation or a foreign body in the ear canal Pain or discomfort in the ear Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user OVATION hearing aids as manufactured do not have this level of output 24 ...

Page 26: ...ate for a hearing aid evaluation The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs If you have reservations about your ability to adapt to amplification you should inquire about the av...

Page 27: ...earing loss DISCLAIMER No hearing aid can restore normal hearing or improve a hearing impairment resulting from organic conditions nor can it prevent further hearing loss You must be patient while adjusting to your hearing aid by wearing it for gradually increasing time periods In most cases full benefits from the hearing aid will occur with regular use The use of a hearing aid is only part of hea...

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