Shining EinScan SE and Rapid Production of Customized Hearing Aids

In this article, we describe the urgent, same-day production of custom earmolds for hearing aids using the Shining 3D EinScan SE scanner. We will look at the case of Hearing Beyond and Frank Talarico as an example.

Learn more by reading the article.

About Hearing Beyond

CARL (Clinical Assistant for Research and Learning). Image by Hearing Beyond.

Frank Talarico is the owner and manager of Hearing Beyond Audiology & Hearing Clinic in Toronto, Canada, a rehabilitation facility for people with hearing impairment, where he uses different, including innovative and creative, methods to help his patients hear and communicate better.

Frank has worked extensively on Project Glia to make hearing care more accessible, and has always tried to find innovative and effective ways to meet his patient’s hearing needs.

Ear geometry measurements and speech-in-noise testing, well-known methods of best audiological practice, have been an integral part of his daily work as an audiologist, as have emergency calls, weekend availability and, more recently, same-day production of custom earmolds.

The Project

Customized ear pieces quickly produced on the day of the order bring many benefits to patients. Frank brought this innovative service to life by using 3D scanning and 3D printing.

How it was done before

Usually, to make earmolds, ear impressions are taken from the patient and mailed to a special lab, then they are manufactured and sent back to the clinic for fitting. This entire process takes one to two weeks.

Applications

Recent advances in ear impression technology have simplified the process with the help of 3D scanners, avoiding making a physical impression of the ear, but the process still takes about a week to get the final product to the clinic.

In addition, if further adjustments and modifications are required for the earmolds, even more shipping time and processing time are added.

Temporary use

With this new technology, a temporary earmold is ready the same day and helps the patient hear while waiting for a more precise product to be made in the lab.

Typically, patients who require hearing aids with custom-made earmolds have severe hearing problems and need their hearing aids to work well all day, every day. The absence of earmolds makes life extremely uncomfortable for such individuals at these times.

Most patients in such a situation will be satisfied with a rented hearing aid, but if a patient requires an impression, commercially available products will not provide sufficient amplification or cannot be used at all.

Urgent production

Rapidly produced molds can also be used for trial use with patients who require devices with high power output, without the need for an uncomfortable foam tip in combination with a BTE (behind-the-ear) or a poorly fitting intracanal hearing aid. An earmold can be made the same day and fitted to a high-power hearing aid, allowing patients with severe hearing loss to hear better as if they had custom-made earmolds from the lab.

Budget Production

Molds done within a day can also be used in resource-limited settings to help people with donated behind-the-ear hearing aids. Charitable clinics often have a supply of donated traditional behind-the-ear hearing aids but no effective means of creating ear pieces. Often these BTE hearing aids are not used precisely because suitable earmolds are not available. The 3D printing method can be used as a solution for such cases.

How it is done now: producing hearing molds within a day

3D printing is universal and ubiquitous, no matter where you are in the world, it has become much more accessible than other precision manufacturing techniques.

Frank began the process of developing a custom ear impression with a standard impression, then used a sharp knife to cut off the extra parts of the impression he didn’t want.

CARL (Clinical Assistant for Research and Learning) with placing the material in the ear. After the impression has set, the excess pieces are cut off. Photo by Hearing Beyond, Toronto.

Using the EinScan-SE desktop 3D scanner, Frank created a 3D scan of an ear liner.

According to Frank Talarico, this scanner offers a high level of accuracy.

After receiving the ear impression scan, some minor digital adjustments were made to correct the flaws in the impression, and a tube opening was added. The scan data was then digitally corrected in Blender.

The ear impression is scanned and digitally processed. Photo by Hearing Beyond, Toronto.

The final step in the one-day process of making a custom earmold is 3D printing. To make the soft earmold, Frank uses a rubber-like material like Flex, which has a Shore hardness of 70A and is soft and resilient.

A 3D printer prints an earmold. Photo by Hearing Beyond, Toronto.

After 3D printing, Frank made sure the earmold fit perfectly, attached the sound tube inside the earmold, and connected it to the patient’s ear and hearing aid. The hearing aid can then be tested and adjusted.

Ear impression and printed earmold, 4.2-3. CARL, with an earmold fitted to the ear, subjected to final measurements. Photo by Hearing Beyond, Toronto.

This adjustment can compensate for severe hearing loss (80 dB HL).It usually takes about two hours to 3D print, but it depends a lot on the size of the earmold and the type of material used.

Flexibility demonstration of Filaflex 70A. Photo by Hearing Beyond, Toronto.

Advantages of 3D printing in making earmolds within a day

Existing emergency earpiece products on the market require that you buy a two-piece kit, but they are usually finicky when it comes to fitting the tube into the mold.

You have to have the patient present to make an impression, and you can only correct these types of products the old-fashioned way: with a grinding or polishing wheel.

With a 3D scanner, the ear impression is saved as a digital file and any adjustments you want to make can be made on the computer with high accuracy.

If you want to add a vent, you can program it into the file. If you want to make the speakers built into the ear pieces, the corresponding adjustment can be made digitally to fit those components. The whole process doesn’t have to be repeated every time like with other technologies.

Also, if you have patient impressions, they can be scanned and printed without the patient being physically present in the office.

One of the biggest advantages is that the technology is completely open:  software, equipment and materials used in this method can be selected without being tied to a specific manufacturer. This makes urgent manufacturing of earmolds available to any hearing care professional.

3D printing has become a widespread manufacturing method in areas with limited resources. Many countries have adopted 3D printing for their own production of stethoscopes, otoscopes and tourniquets to provide themselves with high-quality medical instruments to treat patients; by adapting 3D printing as a manufacturing tool, they can produce high-quality medical devices and consumables on site themselves.


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