Lowering the Barriers to Custom-Fit

/ Updated

Dr. Paolo Masulli

How Scanning, Automation, and Connected Manufacturing are Making Personalized Hearing Products More Accessible

Custom-fit hearing products offer a high degree of acoustic and physical control, yet they are still often reserved for cases where standard fittings are insufficient. The reason is not simply product cost. It is the accumulated friction across impression taking, scanning, modelling, ordering, manufacturing, and delivery.

At the EUHA Live Area, I explored how developments in scanning, automated modelling, and 3D printing could gradually remove that friction and make custom fit a more routine option.

Why acoustic coupling still matters

RIC and open-fit hearing aids have transformed hearing care. They enable fast fittings, reduce occlusion, and work well for many users. But the physical interface between the hearing aid and the ear still affects the sound reaching the eardrum. With a highly open fitting, environmental sound can enter the canal directly and interact with the processed hearing-aid output. This can limit the measurable benefit of features such as directionality and noise reduction in challenging environments.

The conclusion is not that every user needs a closed earmould. It is that seal, venting, retention, receiver position, comfort, and occlusion should be balanced deliberately. Custom fit provides more options for balancing these variables than a limited set of standard tip sizes can offer.

 

Pillar 1: Scanning moves closer to the clinic

Scanning physical silicone impressions is already an established part of digital custom-product manufacturing. Desktop scanners capture a stable physical object under controlled conditions and convert it into a digital model that can be inspected, stored, transferred, and used in CAD software. The physical impression also remains available for comparison or rescanning. 

The more immediate change may therefore be where scanning takes place. When an impression is digitized in or near the clinic, the hearing care professional can review the result while the patient is still present. Missing canal depth, incomplete retention anatomy, folds, or other defects can be identified before the order moves downstream. The digital file can then be transmitted without physically shipping the impression and retained, subject to appropriate clinical and data-governance checks, for replacement or repeat orders.

The greater benefit is not simply speed. It is the creation of an inspectable and traceable starting point for the complete workflow. A digital scan allows the clinic and laboratory to discuss the same visible geometry rather than relying solely on a physical object moving through the supply chain.

 

Pillar 2: Automation compounds human expertise

Modelling converts a scan into a manufacturable earmould, hearing-protection plug, or other custom earpiece.

Digital CAD is now well-established in the industry, having replaced much of the traditional manual sculpting process. Yet modelling remains a scalability bottleneck because it requires specialized expertise, since every design must adapt to unique anatomy while meeting acoustic, material, component, and manufacturing requirements.

Automation and AI are beginning to change that. Current systems can support operations such as impression cleanup, anatomical landmark detection, tip definition, product shaping, vent and sound-bore creation, component placement, and manufacturability checks. The most effective approaches do not treat the product as the output of a single opaque algorithm. They combine learned models with explicit geometry and configurable design rules, which preserve the style and know-how of the earmould manufacturer. 

The most credible operating model is neither fully manual nor fully autonomous. It is selective human oversight.

Routine cases that pass defined quality and manufacturability checks can proceed with limited intervention. Exceptions can be routed to an experienced modeller. In this model, automation applies repeatable rules and previously accumulated knowledge at scale, while experts focus on the decisions where judgment adds the most value.

The purpose of automation is not simply to remove labour. It is to make expert design principles available across more orders, locations, and product categories. 

Pillar 3: Manufacturing becomes more connected and distributed

The manufacturing opportunity lies partly in the printer itself, but also in everything around it: automated print job preparation, order routing, production tracking, material-specific workflows, quality data, and links back to the original scan and design. Integrated production systems can reduce manual handovers while making each order easier to follow through scanning, modelling, printing, finishing, and quality control.

At the same time, improvements in printer speed, affordability, and usability are making lower-volume production more realistic. This does not necessarily mean that every clinic must become a laboratory. Central factories, regional hubs, independent labs, hospitals, and selected clinics may coexist, each producing the products and volumes that fit their capabilities.

Volumetric 3D printing represents a more forward-looking possibility. Rather than constructing an object layer by layer, tomographic systems form geometry within a volume of photosensitive material.
The principle has been demonstrated in research, and early commercial applications are beginning to emerge. Its relevance to custom hearing products will depend on whether it can meet production requirements for materials, accuracy, repeatability, finishing, and cost. If those requirements can be met, volumetric printing could significantly change the economics of small-batch manufacturing.

 

Connecting the pillars: the vision of a same-day workflow

Bringing the three pillars together suggests a future workflow:

  1. The ear or physical impression is scanned in the clinic.
  2. Software checks the input and generates a design using automated modelling and configurable design rules.
  3. Routine orders flow to approval and QA, while uncertain or complex cases are routed to an expert for a thorough review.
  4. The approved design is sent to a suitable central, regional, or local printer.
  5. The finished product is checked, fitted, and linked back to its digital production history.

This is not yet an industry norm. But as these technologies mature and become better connected, same-day custom fit becomes a plausible direction, at least for selected products and workflows.

The deeper change is that the complete chain can become inspectable, repeatable, and traceable: from the representation of the ear, through design decisions and production parameters, to the finished product and fitting outcome.

 

From premium exception to routine option

At 3Shape Audio, we see the greatest opportunity not in optimizing one isolated step, but in improving the connections among scanning, design, production, and quality control. A faster individual technology has limited value if information is still lost between systems or if specialists must repeatedly reconstruct decisions made earlier in the workflow. The long-term goal should be a digital chain in which the input, design intent, production data, and finished product remain connected.

Custom fit does not need to replace open fittings to become more important. It needs to become easier to choose when individual anatomy, retention, comfort, or acoustic control make it the better option.

Scanning can make the input visible and transferable. Automation can apply specialist knowledge more consistently. Connected manufacturing can make production more flexible. Together, these developments can turn custom fit from a workflow defined by friction into one defined by informed choice.

The transition will be gradual, and the right production model will differ among markets and organizations. Personalization and convenience no longer need to be opposing ambitions.

References

  • Winkler, A., Latzel, M. & Holube, I. (2016). Open Versus Closed Hearing-Aid Fittings: A Literature Review. Trends in Hearing.
  • Jürgens, T. et al. (2025). Closedness of Acoustic Coupling and Audiological Measures Are Associated With Individual Speech-in-Noise Benefit From Noise Reduction in Hearing Aids. Trends in Hearing.
  • Denk, F. et al. (2023). Occlusion and coupling effects with different earmold designs - All a matter of opening the ear canal? International Journal of Audiology. 
  • Loterie, D., Delrot, P. & Moser, C. (2020). High-resolution tomographic volumetric additive manufacturing. Nature Communications, 11, 852.
 

Dr. Paolo Masulli

Dr. Masulli is a Senior Product Manager in 3Shape Audio and has been with the company since 2023. Before joining 3Shape, he worked in Research and Development within academia and the health technology industry for more than nine years.

Dr. Masulli has a strong background in technical sciences and product development. He is passionate about the applications of advanced technologies to promote health and well-being, and proud to contribute to the transformation of the hearing industry at 3Shape Audio.