ForgTin® is an innovative behind-the-ear clip produced in additive manufacturing (3D printing in stainless steel and silicone) that significantly reduces tinnitus noise through targeted pressure distribution. ForgTin® serves to reduce tinnitus noise and qualifies as a medical device due to its intended purpose.

 The following figure (Fig. 1) shows the three main areas of action on the ear that are activated by ForgTin®.

Wearing ForgTin® under a helmet in various sports can lead to injury to the ear when putting on or taking off the helmet.  

Wearing ForgTin® during long mobile phone calls can cause the ForgTin® earring to heat up which can cause burns on the body (ears, hands, head).

If ForgTin® is in the bright sun for a long time, the device heats up and can cause burns to the ear, hands or head when attached to the ear.

If ForgTin® is worn at temperatures below 0°C, it can cause frostbite on the ear, hands or head.

When putting on or taking off clothes, make sure that ForgTin® doesn't get stuck to the clothes. This can lead to injuries to the ear or head.

ForgTin® must not be worn on injured skin (only on intact skin!).

When wearing ForgTin® at the same time as Bluetooth headphones, the ForgTin® earring may heat up and cause burns on the body (ears, hands, head).

ForgTin® should not be worn during medical examinations or treatments as this may result in injury to the ear or head.

When ForgTin® comes into contact with thermal water or sea water (salt water), parts of the soft touch silicone on the device can come loose. The exposed parts on the ForgTin® earring can lead to injury to the ear.

When wearing ForgTin®, avoid very close contact with fire sources. Strong heat sources can cause the soft touch silicone parts on the earpiece to ignite, resulting in injuries to the ear, hand or head.

Don't use earplugs from other people as there is a risk of infection.

ForgTin® should not be worn while sleeping at night, as it could lead to unwanted pressure points on the ear.

Pressing the ForgTin® earring too firmly on the ear can also lead to unwanted pressure points on the ear.

Make sure your ForgTin® earband is not set too small and/or the pressure on the tragus is not too high.

This can lead to the following unwanted side effects:

• Headache
• Pressure feeling on the head
• Noise in the ear
• Increase in blood pressure
• Sleeplessness
• tirelessness
• Increase in tinnitus noise
• Change in tinnitus sound (duller, deeper)

If you experience these side effects, reduce the pressure of the ForgTin® Ear Clip and/or reduce the pressure from the lower clip to the tragus. In either case, the clip pressure should be barely noticeable.

Make sure there are no foreign objects on your earpiece - especially on the "rubber parts." This can lead to injury or skin irritation on the ear or head.

Loud music (e.g. at concerts) can cause ForgTin® to resonate with the music, which in turn can lead to unwanted pressure points on the ear.

If the ForgTin® earrings are attached to the ear with too little pressure, the earrings can fall off. Furthermore, the clamping function on the ear decreases and the effect is lost.

During sports (e.g. swimming or running) ForgTin® can fall from the ear and be damaged.

If ForgTin® is worn while making calls, the display of the mobile phone may be scratched.

ForgTin® should not be used on children under the age of 10 as it is not designed for this age group's ear size. The straps are too large and can easily detach.

Please follow the instructions for cleaning ForgTin®, otherwise it may cause damage to the earpiece.

Foreign bodies on the ear clamp can affect the mechanics and thus lead to a reduced or absent effect.

Make sure there is no corrosion on the ForgTin® - mechanical abrasion can get into the ear canal.

Make sure there are no loose rubber parts on the ForgTin® - these can get into the ear canal.

Make sure you attach your ForgTin® to the ear properly, otherwise the effect may be affected. Too much or too little pressure of ForgTin® on your ear cartilage may affect the effect or even cause pain.

Make sure you use ForgTin® according to the instructions to ensure optimal effect.

If ForgTin® is worn with a mouth/nose guard, the device may fall off when removing the mouth/nose guard.

The following figure (Fig.2) shows the main components of ForgTin®.

The following figure (Fig. 3) shows the product ForgTin®.

ForgTin® is made of stainless steel and silicone.

• Silicone: Biocompatibility: ISO DIN EN 10993-05/10993-10
• Stainless Steel: StainlessSteel 316L, complies with the ASTM F138 standard specification

Take your ForgTin® earrings out of the box and put on the earrings according to the picture below.

To this end, the two connected bracket parts are pressed together around the connecting axis until an individual perfect wearing comfort is achieved.

The pressure is set so that the wearing of ForgTin is not even perceived. This pressure can be changed at any time.

The goal is a slight pressure stimulation on three areas of action around the ear – so wearing ForgTin® leads to a reduction of individual tinnitus sounds.

ForgTin® is usually worn on both sides.

The following figure show the proper use of ForgTin®.

Position of upper bracket after application.

Position rear silicone element after application.

Position Tragus element after application.

 ForgTin® is available in different sizes and is usually worn on both ears at the same time. The different sizes depend on the ear circumference of the wearer.

• ForgTin® Small (9-11 cm)
• ForgTin® Medium (11-13 cm)
• ForgTin® Large (13-15 cm)
• ForgTin® X-Large (15-17 cm)

All models are delivered in the Duo version in black.

First registration

After purchasing our product ForgTin®, you will receive your personal license code for the ForgTin® Pro App via email. With this code, you can download and activate the app free of charge. The license is valid for one year from the date of activation.

Schritt 1:
Schritt 1:
Laden Sie die ForgTin® Pro App aus dem App Store oder Google Play Store herunter.

Schritt 2:  
Wählen Sie Ihre bevorzugte Sprache aus und bestätigen Sie die  Nutzungsbedingungen.

 

Schritt 3: 
Erstellen Sie ein neues Benutzerkonto, indem Sie Ihren Vor- und Nachnamen sowie Ihre gewünschte E-Mail-Adresse eingeben. Wählen Sie ein sicheres Passwort, das aus Groß- und Kleinbuchstaben, Zahlen und Sonderzeichen besteht (mindestens 8 Zeichen). 

Bestätigen Sie Ihre Eingaben mit einem Klick auf „Loslegen“.

Schritt 4:

Geben Sie den Lizenzcode ein, den Sie beim Kauf Ihrer ForgTin®-Ohrbügel erhalten haben. Der Code wurde Ihnen per E-Mail zugesendet.

Tagebuch

After successfully signing up, the menu item "Journal" will appear. By regularly answering questions about your tinnitus experience and the underlying symptoms, you can document patterns and changes – helping you to better understand your tinnitus.

​

• Yellow = Tinnitus – Volume
• Pink = Stress

Create a new entry 

Start your entry by clicking the EDIT ENTRY button and track your journal progress over time.

You can make a maximum of two entries per day – with a minimum interval of six hours between them.

In the menu, you also have the option to set reminders to fill out the journal – making it easy to stay on top of your entries.

You can cancel the entry process at any time and return without saving your data.

For a new entry, simply follow the questions and indicate your current state using the sliders.

Knowledge, Exercises, and Listening

In the ForgTin® Pro App, you will find a KNOWLEDGE module that offers comprehensive information about the ForgTin® ear clips, including application instructions, wearing tips, and general information about tinnitus and its treatment options.

The EXERCISES module provides detailed instructions for targeted exercises designed to help relieve somatic tinnitus by strengthening the neck and shoulder muscles and improving flexibility in the head and neck area.

The LISTENING module was specifically developed to support tinnitus therapy through sound stimulation and to reduce the perception of tinnitus. Here, you can choose the sound that best suits you from a diverse sound library.

Allowed Cleaning Agents:
- Clear Water: Suitable for gentle cleaning.
-  Alcohol: Ideal for more thorough cleaning without damaging the material.

Not Allowed:
- Degreasers: These must not be used, as they may damage the materials used (such as silicone).

 If you are not wearing your ForgTin® earbuds, store them in the package that comes with the product. During transport and storage, the temperature must not fall below or exceed -40°C and 200°C.

ForgTin® is a class I medical device. pansatori GmbH hereby declares that the product ForgTin® complies with the following guidelines:

MDR 2017/745 for medical devices CE Class 1.

The statutory warranty provisions apply. The warranty period for our services is one year for business customers and two years for consumers from delivery.

If the customer enters his/her history data regularly (twice daily) and completely within the first two years after the ForgTin® app is first put into operation, the statutory warranty period for the ForgTin®-product will automatically be extended by another year.

ForgTin® is a product made of stainless steel and must therefore be delivered to a corresponding waste material collection point in the area of metals.

Please read this manual carefully to get the most out of  ForgTin® .

This manual includes important warnings and information on how to use the device. If you need more information or have any questions, please contact us.

pansatori GmbH

Managing director of commercial law: Mag. Klaus Grübl

Laabstraße 96
5280 Braunau am Inn, Austria

Tel. 0043 7722 22900
office@pansatori.com

commercial register: FN518780m 
Commercial Register Court: Landgericht Ried i. Innkreis, Austria 
UID: ATU74675069