In clinic
About 30 minutes, physician-applied
Non-invasive placement with no anaesthesia. The family leaves the same visit. Wear time then follows the baby’s age at start.
For doctors · Become a provider
Offer non-surgical infant ear molding in your clinic.
A physician-applied Class 1 set. Application takes about 30 minutes — no anaesthesia, no downtime. Train with our videos, or come to our Ankara centre when you are in Türkiye.
Apply to become a providerWhy clinics add the set
Made for the teams who see infants first.
Training
Videos now. Hands-on in Türkiye.
Start with our application training videos. When you come to our Hacettepe Teknokent centre in Ankara, we train you and your staff in person.
Referrals
Listed on Find a physician
Certified providers appear in our public directory so parents searching in your region can reach your clinic directly.
Indications
What deformities can you treat in clinic?
About 25% of newborns show an ear-shape difference at birth. Some of these settle in the first 10 days. Deformities that remain — about 3–5% of newborns — typically will not self-correct without intervention.
Prominent / cup ear
An ear that stands away from the head, or a cupped bowl that has not opened.
Lidding / lop ear
A folded or hooded helical rim that still looks wrong after the first 10 days.
Stahl’s ear
An extra fold or pointed upper third that can be guided while cartilage is still soft.
Cryptotia and helical rim
A hidden upper pole, a flat rim, or mixed helical-shape differences.
Mixed congenital differences
Combined findings are planned in clinic after the physician names the deformity type.
How we train you
Training videos, or come to our centre in Türkiye.
Physicians and distribution partners who want to work with the set can start with our application videos, then join hands-on training at our Ankara centre when they travel to Türkiye.
Application training videos
Step-by-step modules cover examination, kit placement, follow-up, and how to brief families. We share these with doctors and distributors who apply to work with CranioWell.
On-site training in Ankara
When you come to our centre at Hacettepe Teknokent, we train you and your clinical or field team in person — the same pathway we use with partner clinics today.
Practice support
How we support your clinic.
Clinical and technical training
Video modules for you and your staff, plus on-site workshops at our Ankara centre when you travel to Türkiye.
Kits and material logistics
Single-patient, non-sterile kits for clinic use, with supply for application and follow-up visits.
Parent educational materials
Clinic brochures and digital explainers so new parents understand the first-weeks window.
After training, certified providers can be listed on Find a physician so parents in the region reach the clinic directly. The kit is single-patient and non-sterile, applied only by a physician.
Results
Before and after, from treating physicians.
English clinical cards from CranioWell doctors. Each case was applied and followed in clinic — not at home. Individual results vary with age at start and deformity type.
Dr. Ahmet Kurt
Malatya / Türkiye
Dr. Hikmet Çilli
Gaziantep / Türkiye
Dr. Emilya Efendiyeva
Azerbaijan / Azerbaijan
Pathway
From examination to follow-up
01
Examine and classify
Identify the ear deformity in the first days or weeks of life, while cartilage is still mouldable.
02
Plan duration by age
Wear time follows age at start: 3 weeks from 7–15 days of age, then 4, 5, 6, or 8 weeks as the infant is older.
03
Apply and follow
Place the set in clinic and review regularly. Adjustments stay under your control.
Application
How the set is applied in clinic.
Application in clinic takes about 30 minutes. Molding is typically complete in about a month, with two or three follow-up visits — always under a physician.
01
Hair trimming
Hair around the ear is trimmed so tapes can adhere. The family is asked to wash the baby before the visit.
02
Placement
The main component is seated around the ear in an anatomically correct position.
03
Strips removed
Adhesive backing is lifted and the base is secured to clean skin.
04
Inner parts
Helical and conchal correctors are added according to the deformity. A short trial-fit comes before final placement.
05
Closing the lid
The perforated cap is closed. The ear stays visible and the canal stays open, so hearing continues.
From the user manual
Clinic notes for application and follow-up.
Summary of the English Baby Ear Shaping Kit user manual (v2, 8 January 2025). The full IFU remains the reference for trained physicians.
Preparation
Ask the family to wash the baby at home before the visit. In clinic, trim hair around the ear to about 2 cm, then wipe the skin and the main component with alcohol so tapes can adhere.
Placement
Seat the main component with the ear in an anatomically correct position. Add helical or conchal pieces by type and degree of deformity. Trial-fit the helical corrector; do not let it overlap the antihelix protrusion.
Rear component
Remove the rear component for every child under 2 months of age. After 2 months, decide after measurement and evaluation. Hold the protruding area and pull it out slowly — do not use force.
Inform the family
Explain the procedure before you start. Side effects are uncommon. Ask them to check tapes and the ear from the outside every day. The main component and cap are transparent so the ear can be watched.
Odor, moisture, infection
A slight odor from a closed ear environment can be normal. A strong or abnormal odor means the kit should be checked and removed if needed. Saliva or vomit under tapes can lead to infection — schedule regular checks.
When to bring the baby back
Unusual crying or apparent pain: contact the doctor promptly. Slight tape lift: reinforce with micropore tape from the kit. If the main component comes off completely, the family should come in as soon as possible.
Quality
Certificates you can open and check.
ISO 13485 for medical-device quality, plus 9001, 14001 and 45001 — issued to CranioWell Medikal at Hacettepe Teknokent, Ankara.
ISO 13485:2016
Medical devices — quality management
QMS for the manufacture of orthopedic and related medical products. Certificate no. WRC-CRN-ISO-13485-TR/EN. Valid through 30 September 2026.
Open PDF
ISO 9001:2015
Quality management system
Production, import and export of medical, biomedical, orthopedic and surgical materials. CAS no. MS.0750.1488. Valid through 12 September 2026.
Open PDF
ISO 14001:2015
Environmental management
Environmental management system for the same medical manufacturing scope. FQC no. 14.24.12158.20498.I. Valid through 29 August 2026.
Open PDF
ISO 45001:2018
Occupational health and safety
OH&S management system for medical manufacturing. FQC no. 45.24.12158.30660.I. Valid through 29 August 2026.
Open PDF
Become a provider
Apply for videos, listing, and on-site training
Tell us your clinic and how you prefer to train — application videos, an on-site workshop at our Ankara centre, or both. Application is physician-only.
Certifications & compliance
What buyers and partners can verify.
Class 1 medical device. CE marked. Quality system and national / EU device listings for hospital and ministry files.
- Device class
- Class 1 Medical Device
- CE
- CE marked
- Quality
- ISO 13485:2016 (also ISO 9001, 14001, 45001)
- ÜTS
- Listed in Türkiye ÜTS (medical device registration)
- EUDAMED
- Listed in EUDAMED (EU medical device database)
Certificates (ISO PDFs) are available on the Certificates page. Patent registered with the Turkish Patent and Trademark Office. Origin: Hacettepe Teknokent, Ankara.
View certificates