Clinical UM Guideline

This document addresses the use of prefabricated external infant ear molding systems to treat external ear malformations and deformations. There are several systems currently available, including EarWell^® (Beacon Medical LTD., Batavia, IL) and InfantEar^™ (TalexMedical, LLC, Malvern PA).

Note: Please see ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck for additional information.

Medically Necessary: In this document, procedures are considered medically necessary if there is a significant functional impairment AND the procedure can be reasonably expected to improve the functional impairment.

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect.

Note: Not all benefit contracts/certificates include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

Medically Necessary:

Prefabricated external infant ear molding systems are considered medically necessary when the following criteria are met:

1. Initiation of treatment occurs when the individual is 8 weeks of age or younger; and
2. Treatment is intended to improve a significant functional impairment (for example, impairment of hearing).

Reconstructive:

Prefabricated external infant ear molding systems are considered reconstructive when the following criteria are met:

1. Treatment is intended to address a significant variation from normal; and
2. At least one of the following criteria (1 or 2) are met:
   1. Individual is 8 weeks of age or younger when treatment is started; or
   2. Individual has cryptotia and is 6 months of age or younger when treatment is started.

Cosmetic and Not Medically Necessary:

Prefabricated external infant ear molding systems are considered cosmetic and not medically necessary in the absence of a significant functional impairment or significant variation from normal.

This document describes clinical studies and expert recommendations and explains whether prefabricated external infant ear molding systems are appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Prefabricated infant ear molding systems, such as EarWell and InfantEar, are devices used during early infancy to gently reshape misshapen ears without surgery. These systems apply continuous light pressure to correct deformities or malformations in the external ear, ideally starting treatment within the first few weeks after birth. During this time, the ear cartilage is soft and easier to shape due to high levels of maternal hormones. These systems can improve hearing if the shape of the ear affects sound direction and can also help correct noticeable differences from typical ear anatomy. Research shows these treatments are most effective when started early and are generally safe, with few and mild side effects like skin irritation. However, if used only to change the ear's appearance without any health or structural issues, they are considered cosmetic and not medically necessary.

What the Studies Show

These types of devices are most effective when treatment begins by 6 to 8 weeks of age, as ear cartilage stiffens over time. Studies show that more than 90% of ears treated before 3 weeks of age respond well, and success rates are above 70% if started within 6 weeks. Most complications are minor, like temporary rashes or skin breakdown. In a 2022 meta-analysis of 12 studies using the EarWell system, success rates were about 89% when used early in life. Another large review in 2024 of over 3,000 infants showed the best outcomes in those treated before 4 weeks of age. Both custom-made and prefabricated systems had similar results. Ear molding is also helpful for a condition called cryptotia, where the top of the ear is tucked under the skin. In these cases, reshaping helps bring the ear into a more natural position, especially if treatment begins by 6 months of age. For cryptotia, success may still be possible later than with other ear issues because correction involves stretching skin, not reshaping cartilage. Overall, studies support ear molding as a safe, effective option in infants when used early and for the right medical reasons.

When is Infant Ear Molding Clinically Appropriate?

Infant ear molding systems (such as EarWell or InfantEar) may be appropriate in these situations:

• The infant is 8 weeks of age or younger when treatment starts; and
• Treatment is intended to improve a significant functional problem, such as hearing loss related to ear structure.

Infant ear molding may also be considered reconstructive (not cosmetic) in these situations:

• Treatment is intended to correct a meaningful difference from typical ear anatomy and
• The infant is either:
   1. 8 weeks of age or younger at treatment start; or
   2. Has cryptotia and is 6 months of age or younger at treatment start.

When is this not Clinically Appropriate?

Ear molding is not considered clinically appropriate when there is no clear health benefit. This includes:

• Situations where there is no significant functional hearing issue or
• No noticeable difference from normal ear structure.

This is because studies show that reshaping the ear without a clear medical reason may not improve health. Unnecessary or unproven treatments can lead to treatment that does not help.

Infant ear molding is not clinically appropriate in scenarios other than those listed above.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary or Reconstructive when criteria are met:

Note: if CPT code 21086 (Impression and custom preparation; auricular prosthesis) or HCPCS code L8045 (Auricular prosthesis, provided by a non-physician) are used to describe application or supply of an external ear molding splint system, the criteria in this document will apply.

When services are Cosmetic and Not Medically Necessary:
For the procedure codes listed above when medically necessary or reconstructive criteria are not met, or when the code describes a procedure designated in the Clinical Indications section as cosmetic and not medically necessary.

Summary

Prefabricated external infant ear molding systems are non-surgical devices that apply continuous, gentle pressure to reshape congenital external ear malformations and deformations during early infancy, when auricular cartilage is most malleable; commonly used systems include EarWell and InfantEar. These systems are used to address functional and anatomic concerns associated with congenital ear anomalies, with treatment most effective when initiated within the first weeks of life. Early intervention can improve outcomes for infants with significant functional impairment, such as hearing loss related to abnormal external ear structure, and can correct clinically meaningful variations from normal anatomy, including select cases of cryptotia treated beyond the immediate neonatal period. In contrast, use in the absence of functional impairment or significant anatomic variation is generally limited to aesthetic considerations. Clinical evidence demonstrates high rates of successful correction, particularly with early initiation, and low rates of typically mild and transient complications, supporting the use of ear molding in appropriately selected infants.

Discussion

Ear anomalies are categorized as malformations (partial or complete absence of skin and cartilage) or deformations (misshapen cartilage with no underlying skin or cartilage deficiencies). Auricular deformations make up the majority of congenital ear anomalies (Anstadt, 2016). Approximately 30% of infant ear deformities will self-correct or experience spontaneous improvement within the first few weeks of life. However, the majority of malformations generally do not improve spontaneously over time (Bhatti, 2021; Burns, 2023). Given that there is no reliable system to predict which cases will self-correct and the short window of opportunity in which the ear tissue is malleable, non-surgical treatment should be initiated as soon as possible in affected infants. Surgical correction has been used as a method of correction for more severe cases or when non-surgical treatment is not an option. Surgery is typically deferred until after age 5, when the ear has reached at least 90% of its adult size.

Ear molding has been used as a method of normalizing the shape of the ear by applying direct, continuous pressure. Appropriate ear molding needs to meet several clinical criteria. Anstadt (2016) lists the following criteria: devices “should be delicate enough to reduce the risk of pressure ulcers, should be nonirritating to the skin to reduce risk of dermatitis, should be malleable to achieve the optimal ear shape …”. Reshaping of auricular deformities using non-surgical ear molding techniques is possible due to the malleability of infant ear cartilage. The type and severity of the anomaly appears to be a factor in the success rate. The age at treatment initiation is also very important; treatment initiated at 3 weeks of age or younger has generally reported better outcomes with shorter treatment periods. After 6 to 8 weeks, there is a recognized loss of pliability and increased stiffness in the infant cartilage (Daniala, 2023). Molding materials such as foam, tape, wires, feeding tubes, tape, wax, and putty vinyl polysiloxane impression material have been used for non-surgical correction (Anstadt, 2016). Several prefabricated kits are available, including the Earwell and InfantEar systems.

Age at Treatment Initiation

Ideally, treatment is initiated soon after birth. Within this time period, the increased malleability of cartilage is thought to be related to the high levels of circulating maternal estrogen. Estrogen levels typically peak within a few days following birth and then begin to decline by 6 weeks of age. When treatment is begun within 3 weeks postpartum, there is a success rate of 90% or greater. When treatment is initiated within 6 weeks, positive results of greater than 70% are reported (Daniali, 2017; Mohammadi, 2016; Nigam, 2020; Roby, 2023; Wu, 2022). Treatment initiated at an earlier age generally requires a shortened treatment period (Doft, 2015; van Wijk, 2009). Given this, use of prefabricated external infant ear molding systems is considered with generally accepted standards of medical practice when initiation of treatment occurs in individuals 8 weeks of age or younger.

Wu and colleagues (2022) examined the safety and effectiveness of EarWell Ear Correction Kit in the treatment of congenital auricle malformation. The meta-analysis included a mix of 12 retrospective and prospective studies. A total of 1027 ears were included in the analysis. The effective rate for correcting congenital auricle malformation was 89.1%; higher rates were reported when therapy was initiated earlier in life. The efficacy of therapy was reported at higher than 80% if initiated within 6 months of birth. The incidence of complications was reported at 11.4% and consisted mainly of skin lesions and dermatitis. This meta-analysis consisted of single arm retrospective and prospective studies and is associated with high heterogeneity. The authors noted that 9 of the 12 studies were from China and noted that further verification would be needed to determine whether the study results could be applied to individuals from other countries.

In 2022, Saba and associates conducted a systematic review and meta-analysis to assess the efficacy of ear molding therapy. The meta-analysis included 15 studies and 2508 ears, primarily involving ear deformities rather than malformation. The studies included prefabricated devices and non-fabricated devices. There was a high level of heterogeneity among the studies. However, the results showed higher success when treatment was initiated at 3 weeks of age or younger. Reported complications (eczema, excoriation, infection, irritation, rash, and ulceration) were minor and transient. The analysis concluded that ear molding is safe and effective when used to treat congenital ear anomalies in appropriate populations.

A systematic review of 37 studies involving 3,341 individuals with a variety of ear anomalies examined the effectiveness of nonsurgical ear molding for congenital ear anomalies (Sulibhavi, 2024). The average age at treatment initiation was 4.82 weeks and the median age was 3.7 weeks. Infants younger than four weeks at the start of treatment showed the best outcomes in terms of ear contour correction, requiring shorter treatment durations and achieving higher satisfaction rates. The analysis included both individualized and commercial devices. There was no significant difference in correction or complication rates between them, although complications such as dermatitis and skin breakdown were common.

Functional Impairment

The outer ear consists of several cartilaginous structures which serve to direct sound waves into the external auditory ear canal and the tympanic membrane (Sánchez López de Nava, 2023). Hearing may be affected when there are abnormalities of the auditory ear canal or tympanic membrane and repair of these structures can improve hearing. Neonatal hearing loss can result from transient or permanent conductive, permanent sensorineural, auditory neuropathy, and mixed defects. Hearing loss in infancy can lead to delayed language development, difficulties with behavior and psychosocial interactions, and poor academic achievement. Significant functional hearing impairment in an infant may result from a physical structure or absence of a physical structure that is causing hearing loss of at least 15 decibels in the affected ear(s).

Ear molding is considered reconstructive when it is intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect. When neither reconstructive criteria nor functional impairment are present, ear molding is considered cosmetic.

Cryptotia

In cryptotia, the cartilaginous framework of the ear is typically normal, but the upper third of the ear lies under the skin. Some cartilage deformities of the upper ear may also be present. Non-surgical ear molding beyond 8 weeks has been shown to be beneficial in this population (Saba, 2022; Xu, 2023; Zhou, 2019). Unlike in most ear deformities, which are aimed at cartilage remodeling, correction of cryptotia involves the expansion of the retroauricular skin to cover the embedded cartilage. The outer ear supports eyeglasses, hearing aids, or mask wear; ideally, the anatomic landmarks of the ears should align with each other to allow for symmetric or near symmetric use of the device being supported (Susarla, 2022).

Chia and colleagues (2021) describe a non-surgical treatment modality of cryptotia in 5 infants aged 1 day to 7 months. All infants (n=5) were initially treated with 2 weeks of continuous medical distraction to unbury the auricle using the EarWell Infant Ear Correction System. The placement of the retractor was customized to address the inherent helical constriction and expand the helix. Infants under 6 weeks of age at initiation (n=2) were treated with an additional 2 weeks of helical molding to correct any residual deformities. All infants were evaluated by 2 blinded plastic surgeons and rated as having good to excellent results. At 1 year, all helices remained retracted. The authors explained why non-surgical molding was effective in older infants, noting:

Our 2-stage approach addresses the two key pathologies of cryptotia. Unburying of the auricle is addressed in the first stage with the sustained distraction of the buried auricle out of the temporal skin pocket for 2 weeks. It is postulated that the excessively developed intrinsic transverse or oblique auricular muscles result in cryptotia. The aim is to stretch the skin and auricular musculature and also initiate distraction histogenesis. This stage, unlike the second stage, is independent of cartilage pliability and, hence, the patient’s age. It can be performed in older infants, provided the auricle is retractable, suggesting that the auricular muscles have not undergone fibrosis.

Prefabricated Systems

Success has been reported with non-prefabricated splinting systems with efficacy rates and complication rates comparable to the prefabricated kits (Anstadt, 2016; Chang, 2017; Manji, 2020; Mohammadi, 2016; Woo, 2017). Lennon and associates (2018) note that a benefit of the custom-made molds is that the materials are familiar, easily available and may be better able to address conchal bowl and inferior rim/lobular anomalies. Prefabricated devices are more convenient, and some devices may have the ability to mold ears both laterally and medially, and more rigid fixation may allow for improved treatment of more complex ear lesions.

Anotia: Malformation in which the external ear is absent.

Constricted ear: A group of deformities in which there is an abnormal chondrocutaneous distribution of the superior helix. These deformities include lidded ear, lop ear and cup ear.

Cryptotia: Malformation in which the ear cartilage is partially located under the temporal scalp skin. Cryptotia is caused by the improper fusion of the cartilage of the ear and the overlying skin in utero.

Deformation: Misshapen cartilage with no underlying skin or cartilage deficiencies.

Functional impairment: Significant functional impairment may include physical, social, emotional, and psychological impairments or potential impairments. Examples of limits on normal physical functioning include problems with hearing, communication, respiration, eating, swallowing, visual impairments, skin integrity, distortion of nearby body parts, obstruction of an orifice. The cause of the functional impairment may be pain, structural integrity, congenital anomalies, or other factors.

Helical Rim Deformities: Deformity that affects the anatomic semicircular contour of the outer rim.

Microtia: Malformation in which the external ear is underdeveloped.

Prominent ear: Deformity in which the auriculocephalic angle (projection of the ear from the mastoid process) exceeds the normal 20 to 30 degrees or when upper ear protrusion is greater than approximately 2 cm in the mature ear.

Stahl ear: Deformity which affects the upper third of the ear, characterized by the presence of an extraneous third crus in the auricular cartilage.

Peer Reviewed Publications:

1. Anstadt EE, Johns DN, Kwok AC, et al. Neonatal ear molding: timing and technique. Pediatrics. 2016; 137(3):e20152831.
2. Bhatti SL, Daly LT, Mejia M, Perlyn C. Ear abnormalities. Pediatr Rev. 2021; 42(4):180-188.
3. Burns HR, Dinis J, Ding Y, Buchanan EP. Seminars in plastic surgery: pediatric ear anomalies and reconstruction. Semin Plast Surg. 2023; 37(4):287-298.
4. Byrd HS, Langevin CJ, Ghidoni LA. Ear molding in newborn infants with auricular deformities. Plast Reconstr Surg. 2010; 126(4):1191-1200.
5. Chang CS, Bartlett SP. A simplified nonsurgical method for the correction of neonatal deformational auricular anomalies. Clin Pediatr (Phila). 2017; 56(2):132-139.
6. Chia DH, Sim N. Non-surgical correction of cryptotia. J Plast Reconstr Aesthet Surg. 2021; 74(2):377-381.
7. Daniali LN, Rezzadeh K, Shell C, et al. Classification of newborn ear malformations and their treatment with the EarWell Infant Ear Correction System. Plast Reconstr Surg. 2017; 139(3):681-691.
8. Doft MA, Goodkind AB, Diamond S, et al. The newborn butterfly project: a shortened treatment protocol for ear molding. Plast Reconstr Surg. 2015; 135(3):577e-583e.
9. Feijen MMW, van Cruchten C, Payne PE, van der Hulst RRWJ. Non-surgical correction of congenital ear anomalies: a review of the literature. Plast Reconstr Surg Glob Open. 2020; 8(11):e3250.
10. Lennon C, Chinnadurai S. Nonsurgical management of congenital auricular anomalies. Facial Plast Surg Clin North Am. 2018; 26(1):1-8.
11. Manji I, Durlacher K, Verchere C. Correction of neonatal auricular deformities with DuoDERM: a simple technique. Paediatr Child Health. 2020; 26(5):270-273.
12. Matsuo K, Hayashi R, Kiyono M, et al. Nonsurgical correction of congenital auricular deformities. Clin Plast Surg. 1990; 17(2):383-395.
13. Mohammadi AA, Imani MT, Kardeh S, et al. Non-surgical management of congenital auricular deformities. World J Plast Surg. 2016; 5(2):139-147.
14. Nigam M, Kotha VS, Barra C, Baker SB. Nonoperative molding of congenital ear deformities: the impact of birth-initiation delay on correction outcome. J Craniofac Surg. 2020; 31(6):1588-1592.
15. Porter CJ, Tan ST. Congenital auricular anomalies: topographic anatomy, embryology, classification, and treatment strategies. Plast Reconstr Surg. 2005; 115(6):1701-1712.
16. Roby BB, Woods T, Chinnadurai S. Update on congenital ear molding. Curr Opin Otolaryngol Head Neck Surg. 2023; 31(4):215-218.
17. Saba ES, Mui S, Schloegel LJ. Noninvasive ear molding in the correction of ear anomalies: a systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. 2022; 159:111189.
18. Sánchez López de Nava A, Lasrado S. Physiology, Ear. 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.
19. Sulibhavi A, Reddy SP, Butts SC, Schmalbach CE. Ear molding in children-timing, technique, and follow-up: a systematic review. Facial Plast Surg Aesthet Med. 2024; 26(6):730-739.
20. Susarla SM, Park J, Sie K. Mask wear: an important consideration in patients with microtia. J Oral Maxillofac Surg. 2022; 80(4):590-591.
21. van Wijk MP, Breugem CC, Kon M. Non-surgical correction of congenital deformities of the auricle: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2009; 62(6):727-736.
22. Woo JE, Park YH, Park EJ, et al. Effectiveness of ear splint therapy for ear deformities. Ann Rehabil Med. 2017; 41(1):138-147.
23. Wu D, Li L, Zhou M. Treatment of congenital auricle malformation with EarWell Ear Correction Kit: a meta-analysis. Ear Nose Throat J. 2022: 1455613221122589.
24. Xu H, Ding S, Yang H, et al. The treatment effect of non-surgical ear molding correction in children with mild cryptotia deformity. Laryngoscope. 2023; 133(9):2122-2128.
25. Zhou Z, Chen C, Bi J, et al. Study on application of ear correction model to infantile cryptotia. Int J Pediatr Otorhinolaryngol. 2019; 118:62-67.
26. Zou Q, Zhao S, Wang D, et al. Comparison of two conchal formers for nonsurgical correction on Conchal Crus. Laryngoscope Investig Otolaryngol. 2022; 8(1):279-286.

1. American Academy of Pediatrics (AAP)- Healthy Kids. Sound Options: Treating Abnormal Ear Shape in Infants and Children. Last Updated February 1, 2018. Available at: https://www.healthychildren.org/English/health-issues/conditions/Cleft-Craniofacial/Pages/Abnormal-Ear-Shape-in-Infants-and-Children.aspx. Accessed on January 6, 2026.
2. American Society of Craniofacial Surgeons. Ear molding. Available at: https://ascfs.org/Patients/Conditions/Ear-Molding.cgi. Accessed on January 6, 2026.
3. Centers for Disease Control and Prevention (CDC). Facts about Anotia/Microtia. Last reviewed December 26, 2024. Available at: https://www.cdc.gov/birth-defects/about/anotia-microtia.html?CDC_AAref_Val=https://www.cdc.gov/ncbddd/birthdefects/anotia-microtia.html. Accessed on January 6, 2026.

EarWell
InfantEar
Earbuddies^® (Earbuddies, London, England)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.