Introduction
EarCheck PRO™ is an advanced medical
instrument that accurately detects the presence of middle ear fluid (i.e.,
otitis media with effusion) that may be associated with acute ear infection.
The instrument is designed for use by medical professionals on children
from 6 months to young adult. The instrument determines the condition of
the middle ear by measuring the response of the eardrum to sound stimulus.
Using a built-in microphone and microprocessor, it registers the intensities
of different frequencies of a reflected sound and analyzes the results.
The results are then correlated to the probability of middle ear effusion.
Product
Overview and Description
The EarCheck
PRO™ analyzes the resonance characteristic of the eardrum by measuring
the Spectral Gradient angle of the eardrum's resonance curve, thereby indicating
the condition of the middle ear. In a normal ear cavity, the eardrum has
full freedom of motion, producing a shallow, wide-angle curve. When fluid
is present, the motion of the eardrum is restricted and a narrower curve
results. The EarCheck PRO™ performs this analysis internally and displays
the resulting angle. For convenience of interpretation, this measure is
scaled in such a way as to correspond to angles measured on plots of reflectance.
The Spectral Gradient angle corresponds to the Risk of Disease (Otitis Media)
as shown on table below. The lower the Spectral Gradient angle, the more
likely the risk of disease. This table also appears on the EarCheck PRO™
instrument.
| Spectral
Gradient |
Risk
of Disease |
| Level |
Angle |
|
|
5
|
<49° |
High |
|
4
|
49°-
59° |
Moderate-High |
|
3
|
60°-
69° |
Moderate |
|
2
|
70°-
95° |
Low-Moderate |
|
1
|
>95° |
Low |
Product
Use and Procedure
Before
using EarCheck PRO™, you must test the instrument using the Verification
Tube to ensure that it is functioning properly. EarCheck PRO™
uses sound waves to detect fluid and should be used in a quiet environment.
|
 |
1. |
Place child in an upright position, sitting or standing. |
| 2. |
Grasp
the outer edge of the child's ear. Firmly pull the ear straight back
and up. Continue "ear tug" throughout the test procedure.
You may need to try several different "ear tugs" to obtain
an accurate reading. |
| 3. |
Gently
place the tip of the EarCheck PRO™ into the child's outer ear
canal behind the Tragus. Completely cover the ear canal. |
| 4. |
Press
and hold the appropriate SCAN button for approximately 5 seconds.
Press "R" SCAN button for the right ear and press the "L"
SCAN button for the left ear. Continue holding the SCAN button until
the lowest Spectral Gradient angle obtained appears on the display
panel. |
| 5. |
Release
the scan button before removing EarCheck PRO™ from the child's
ear and read results.
Important: Failure to release the SCAN button before removing
the tip from the ear canal will cause the instrument to continue taking
readings.
Note: EarCheck PRO™'s Spectral Gradient Angle will remain
displayed for 10 seconds after the SCAN button has been released. |
| 6. |
Repeat
steps 1-to-5 with the child's other ear |
Features
and Benefits
|
Accurate- Objectively determines
the presence of middle ear effusion. The EarCheck PRO™ is clinically
proven to be equivalent to tympanometry in detecting middle ear effusion.
|
No
Patient Response- Minimal cooperation is required, making
it ideal with young children, special needs populations and/or whenever
there are language barriers. The EarCheck PRO™ does not rely
on a child's response.
|
Objective-
Otoscope relies on a subjective assessment, while the EarCheck
PRO™ analyzes reflected sound to detect effusion.
|
Small,
Lightweight and Portable- No bulky wires; ergonomic design.
|
Comfortable
and Simple- Can be used in seconds and requires no set-up,
airtight seal, pressurization of ear canal or even a direct line of
sight to the eardrum..
|
Disposable
Probe tips for cleanliness
|
| Easy
to read LCD with reference chart- Results displayed in
seconds, low incidence of error and uninterpretable readings. |
| Cost
effective- Uses readily available AA Alkaline Batteries,
displays low battery warning; requires no re-calibration. |
| Affordable
and Reimbursable- Less than half the cost of a tympanometer.
Most insurers will reimburse under impedance testing (CPT code 92567). |
| Latex-Free-
Both the EarCheck PRO™ device and the EarCheck PRO™
Disposable Plastic Tips are latex-free as specified in the 501 (k)
documents on file with the FDA |
| Optional
storage base- Protects the instrument when not in use.
|
Frequently
Asked Questions
| Q: |
I
can see what is going on in the ear with my otoscope. Why do I need
something to tell me what I can already see? |
| A: |
Fluid can be difficult
to detect and a red eardrum may not be indicative of middle ear effusion.
|
| Q: |
How
does the EarCheck PRO™ technology compare to that of the tympanometer? |
| A: |
The EarCheck PRO™
analyzes reflected sound to detect effusion; tympanometry requires
a pressurized ear canal.
|
| Q: |
The
disposable ear tips seem too big. Can I use them on young children
with small ear canals? |
| A: |
The disposable tip
is 10mm in diameter. A tight seal is not required, it only needs to
fit over the opening of the ear canal. The EarCheck PRO™ does
not require a direct line of sight.
|
| Q: |
Can
I hurt the child's eardrum if I insert the tip too far? |
| A: |
The EarCheck PRO™
disposable tip is designed to prevent it from being inserted too far
into the ear canal.
|
| Q: |
What
about earwax, will it interfere with the readings? |
| A: |
The EarCheck PRO™
device will provide accurate readings in the presence of partial amounts
of wax.
|
| Q: |
On
what age group may the EarCheck PRO™ be used? |
| A: |
Use only on children
ages 6 months to young adult.
|
| Q: |
Can
I use the EarCheck PRO™ on a child lying on their napping cot? |
| A: |
The EarCheck PRO™
should only be used on a child that is sitting or standing in an upright
position.
|
| Q: |
If
I already own a tympanometer should I use the EarCheck PRO™? |
| A: |
A tympanometer is
difficult to use when a child is uncooperative or in pain. Tympanometry
is technique dependent, requiring an ear seal and a pressurized ear
canal. It is also very hard to perform on children under the age of
2 - the largest population with otitis media.
|
| Q: |
Can
the EarCheck PRO™ be used with the presence of middle ear effusion? |
| A: |
The EarCheck PRO™
should not be used if there is presence of infection, drainage of
pus or blood in the ear canal. The EarCheck PRO™ is also contraindicated
for:
 |
Children with
ventilation tubes |
|
Children with
perforation of the eardrum |
|
Children with
facial or eardrum deformities |
|
Children with
impacted cerumen |
|
Technical
Specifications
| Dimensions:
|
7.0
in-H, x 2.75 in-W, x 2.5 in-D (169mm x 87mm x 87mm) |
| Weight:
|
6.2
oz (174 g.) (With Batteries) |
| Measuring
Range: |
1.8
kHz to 4.4 kHz |
| Sound
Volume: |
80
dB. SPL (±6dB) |
| Sound
Duration: |
.2-second
sweep |
| Display:
|
LCD
display |
| Display
Hold Time: |
10 sec. |
| Power: |
Two AA Alkaline Batteries |
| Battery
Symbol: |
Low Battery |
| Battery
Life: |
1000
readings in 4 months |
| High
Noise Level: |
Error Indicator |
| Ambient
Temperature Operating Range: |
+50°F
to +95°F (15°C to 35°C) |
| Relative
Humidity Operating Range: |
<75% |
| Storage
Temperature Range: |
-4°F to +122°F (-20°C to +50°C) |
| Relative
Humidity Storage Range: |
<85% |
Articles
Click
here to read an article by Dr. Jerome Combs and Dr. Andrew Schuman in
Contemporary Pediatrics magazine. The article is titled Three Technologies
for Taming Otitis Media.
The prestigious Cleveland
Clinic just issued a supplement to its journal which focuses on the new
otitis media guidelines. Please click HERE
to read the favorable review of the Ear Check and Acoustic Reflectometry.
Warranty
Limited
1 Year-Professional Use
Reimbursement
Reimbursable (CPT code 92567) for impedance testing.
Product Ordering Information
| SH
Catalog # |
Product
Name |
| 53066 |
EarCheck
PRO™ Otitis Media Detector |
|
