ear impression requirements...cerumen in ear canal all cerumen that would interfere with obtaining a...

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Cerumen in ear canal All cerumen that would interfere with obtaining a full impression of the unobstructed ear canal should be removed prior to taking the impression. Cerumen embedded in impression A small amount of cerumen on the surface of the impression is normal and acceptable. However, large particles that could fall off during transportation resulting in a void are unacceptable. Disclaimer The following is not intended to provide instructions for properly and safely obtaining ear canal impressions. It is intended to be a reference for the properly trained practitioner to obtain the correct impression materials and to define the characteristics of an acceptable ear impression. These characteristics are critical for the proper production of Aegisound hearing protection products. The following guidelines are in no way a substitute for proper training and applicable regulatory licensure. The impression taking process should only be undertaken by an audiologist or other properly trained personnel. CONDITIONS TO WATCH FOR OUTER EAR FILL AREA EAR IMPRESSION REQUIREMENTS Impression Material Otoform ® A SoftX or SiliClone ® low viscosity impression material. Low viscosity material is critical to prevent expansion of the ear canal during the impression process. Jaw Position Closed and relaxed, no jaw movement or talking during the impression material cure period (7-10 minutes typical for SiliClone ® ) Impression Depth The impression material must extend at least 1mm past the completed 2nd bend (3mm past the bend is preferred). The impression must indicate the size and direction of the canal after the 2nd bend. Material Fill The impression material should fill the entire canal as well as the helix and concha areas of the outer ear. Ear Dam/Oto-block vent tube If using a vent tube, the tube may be embedded on the surface of the impression as long as the impression material fills around the tube and the surface is well defined. Fully Impressed Concha and Antihelix Boundary Desired Impression Area Full Impression of Tragus and Antitragus Boundary 645 Harvey Road, Road, Suite 102 Manchester, NH 03103 Tel: 866.951.1027 Fax: 603.657.1201 www.gentexcorp.com/aegisound Gentex Corporation Copyright © 2018 Gentex Corporation. Gentex and Aegisound are registered trademarks of Gentex Corporation or its affiliates. Otoform is a registered trademark of Dreve Otoplastik GmbH. SWF-00152 Rev B

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Page 1: EAR IMPRESSION REQUIREMENTS...Cerumen in ear canal All cerumen that would interfere with obtaining a full impression of the unobstructed ear canal should be removed prior to taking

Cerumen in ear canal All cerumen that would interfere with obtaining a full impression of the unobstructed ear canal should be removed prior to taking the impression. Cerumen embedded in impression A small amount of cerumen on the surface of the impression is normal and acceptable. However, large particles that could fall off during transportation resulting in a void are unacceptable.

Disclaimer The following is not intended to provide instructions for properly and safely obtaining ear canal impressions. It is intended to be a reference for the properly trained practitioner to obtain the correct impression materials and to define the characteristics of an acceptable ear impression. These characteristics are critical for the proper production of Aegisound hearing protection products.

The following guidelines are in no way a substitute for proper training and applicable regulatory licensure.

The impression taking process should only be undertaken by an audiologist or other properly trained personnel.

CONDITIONS TO WATCH FOR

OUTER EAR FILL AREA

EAR IMPRESSION REQUIREMENTS

Impression Material

Otoform® A SoftX or SiliClone® low viscosity impression material. Low viscosity material is critical to prevent expansion of the ear canal during the impression process.

Jaw PositionClosed and relaxed, no jaw movement or talking during the impression material cure period (7-10 minutes typical for SiliClone®)

Impression Depth

The impression material must extend at least 1mm past the completed 2nd bend (3mm past the bend is preferred). The impression must indicate the size and direction of the canal after the 2nd bend.

Material FillThe impression material should fill the entire canal as well as the helix and concha areas of the outer ear.

Ear Dam/Oto-block vent tube If using a vent tube, the tube may be embedded on the surface of the impression as long as the impression material fills around the tube and the surface is well defined.

Fully ImpressedConcha and

Antihelix Boundary

DesiredImpressionArea

Full Impressionof Tragus andAntitragusBoundary

Fully ImpressedConcha and

Antihelix Boundary

DesiredImpressionArea

Full Impressionof Tragus andAntitragusBoundary

Fully ImpressedConcha and

Antihelix Boundary

DesiredImpressionArea

Full Impressionof Tragus andAntitragusBoundary

Fully ImpressedConcha and

Antihelix Boundary

DesiredImpressionArea

Full Impressionof Tragus andAntitragusBoundary

645 Harvey Road, Road, Suite 102 Manchester, NH 03103 Tel: 866.951.1027 Fax: 603.657.1201 www.gentexcorp.com/aegisound Gentex Corporation

Copyright © 2018 Gentex Corporation. Gentex and Aegisound are registered trademarks of Gentex Corporation or its af�liates. Otoform is a registered trademark of Dreve Otoplastik GmbH. SWF-00152 Rev B

Page 2: EAR IMPRESSION REQUIREMENTS...Cerumen in ear canal All cerumen that would interfere with obtaining a full impression of the unobstructed ear canal should be removed prior to taking

ACCEPTABLE IMPRESSION

UNACCEPTABLE IMPRESSIONS

EAR IMPRESSION REQUIREMENTS

Canal Length ■ Inflection point must be identified before assessing acceptable canal length

■ Inflection point: When the curvature of the 2nd bend ends and the canal becomes relatively straight, a clear direction in which the canal is heading in can be determined; the earliest point on the impression where this can be determined is the inflection point

■ Once inflection point is identified,1mm beyond the point is the minimal length needed for production of final product, 3mm beyond is desired

■ Requirements apply to all other perspective views (only 1 shown for example)

3mm Preferred Length

1mm Minimal Length

In�ection Point

3mm Preferred Length

1mm Minimal Length

In�ection Point

RIps/Tears ■ There should be no rips or tears along ear canal

Missing Fill ■ There should be no missing fill along ear canal

Too Short ■ Impression should extend 3mm past inlfection point (see above)

Bubble ■ There should be no bubbles along ear canal

Shiny Surface Area ■ There should be no shiny surface area where fill did not make contact with skin

645 Harvey Road, Road, Suite 102 Manchester, NH 03103 Tel: 866.951.1027 Fax: 603.657.1201 www.gentexcorp.com/aegisound Gentex Corporation

Copyright © 2018 Gentex Corporation. Gentex and Aegisound are registered trademarks of Gentex Corporation or its af�liates. Otoform is a registered trademark of Dreve Otoplastik GmbH. SWF-00152 Rev B

Page 3: EAR IMPRESSION REQUIREMENTS...Cerumen in ear canal All cerumen that would interfere with obtaining a full impression of the unobstructed ear canal should be removed prior to taking

GENTEX CORPORATION

CUSTOM EARPLUG INFORMATION 

EARPLUG CLIENT INFORMATION IMPRESSION INFORMATION*

FIRST NAME*DATE IMPRESSIONS TAKEN 

[DD/MM/YYYY]

MIDDLE INITIAL IMPRESSION TAKER LAST NAME 

LAST NAME* IMPRESSION TAKER FIRST NAME 

DATE OF BIRTH [DD/MM/YYYY] IMPRESSION TAKER CONTACT INFO

EMAIL EMAIL 

PHONE NUMBER  PHONE NUMBER

WORKSITE INFORMATION 

(BASE/SQUADRON/COMPANY/ETC)*

UNIQUE FOUR DIGIT IDENTIFIER 

CHOSEN BY END USER*

COMPANY NAME*

CONTACT PERSON

PHONE 

EMAIL 

TYPE OF EARPLUGS AND NUMBER OF EACH REQUESTED (IF KNOWN)Part Number Description Quantity (Pairs) SHIPPING NOTES:

05‐016020 LPCCE  Ship Impressions to: 

05‐001003 CTE30X

05‐016032 FCCCE

05‐021001 DANR 

PURCHASE ORDER NUM.

PAYMENT METHOD

SHIPPING ADDRESS

*Indicates required information

Impression ID numberInspection Date

Disposal Date (3 months after SO received)

Inspection Result ACCEPT Inspector Initials

Reason/Comments

REJECT

‐‐‐‐‐THIS AREA FOR GENTEX FACTORY USE ONLY ‐‐‐‐‐

Each impression shall be individually bagged. Print and include this form.Impression(s) shall be surrounded by corrugate/paper free protective dunnage(bubble wrap, foam sheet, Airpak, etc.)

GENTEX CORPORATION 

Attn: Ear Impressions

645 Harvey Road, Suite, 102

Manchester, NH 03103

BILLING METHOD (IF AVAILABLE)

AUDIOLOGIST/HEARING TECHNICIAN COMMENTSCOMPANY INFORMATION

ANY OTHER COMMENTS?:

ANY DIFFICULTIES MEETING 

STANDARDS LISTED ON IMPRESSION 

REQUIREMENTS FLYER?