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Defines medical necessity, experimental/investigational determinations, limitations/exclusions, device replacement/upgrade rules, and applicable CPT/HCPCS/ICD-10 codes for implantable and non-implantable bone-anchored hearing aids.
No material clinical or coverage changes in this update.
Payer: Aetna. Policy title: Bone-Anchored Hearing Aids (Clinical Policy Bulletin Number 0403), Effective Date: 2000-03-09. Status: CURRENT (last review noted 2024-02-16).
High-level stance: Mixed — implantable/osseointegrated bone-anchored hearing aids (BAHAs) are considered medically necessary for specified indications and audiologic thresholds; other uses and certain non-osseointegrated or partially implantable devices are experimental/investigational or not medically necessary when criteria are not met.
Key eligibility headline: Implantable BAHA is generally covered for persons aged ≥5 years with unilateral or bilateral conductive or mixed hearing loss or for single-sided deafness (SSD) when the specific clinical and device-specific audiometric criteria are met. Non-osseointegrated devices (e.g., soft band, SoundArc, Adhear) are not covered under plans that exclude hearing aids except as a temporary bridge for children <5 years who meet BAHA candidacy criteria.
Medical Necessity - Eligible Candidates (age >=5)
Covered when ALL of the following are met:
ALL of the following
Contraindication to air-conduction aids
Device-specific listing: <=45 dB HL for BAHA Attract, BAHA Divino, BAHA BP100, Baha 4, Bonebridge, Cochlear Osia/Osia 2/Osia B1300, Sophono Alpha System; <=55 dB HL for BAHA 5 Power, Baha 5 Super Power, Baha 6 Max, BAHA Intenso, Ponto Plus Power; <=65 dB HL for BAHA Cordelle II
Symmetric bone conduction threshold defined as either: for BAHA Divino/Ponto series/Sophono Alpha: <=10 dB average difference (0.5,1,2,4 kHz) OR <15 dB at individual frequencies; for BAHA Attract/BAHA BP100/BAHA 4/BAHA 5 Power/Baha 5 Super Power/Baha 6 Max/BAHA Cordelle II/BAHA Intenso/Bonebridge/Cochlear Osia systems: <=10 dB average difference (0.5,1,2,3 kHz) OR <15 dB at individual frequencies
A unilateral sensorineural hearing loss at a non-functional/non-amplifiable level is an indication for a BAHA implant
Medical Necessity - Single-Sided Deafness (SSD)
Covered when ALL of the following are met:
When device-specific indications require it, document AC PTA of better-hearing ear <= 20 dB HL (0.5,1,2,3 kHz)
Replacement / Upgrade of BAHA Components
Covered when ALL of the following are met:
Replacement/upgrade criteria
Operational exclusion
Experimental and Investigational (Not Medically Necessary)
Aetna considers the following experimental and investigational:
Policy limitations and exclusions: Aetna follows Medicare in classifying osseointegrated implants (implantable BAHAs and temporal bone stimulators) as prosthetics; non-osseointegrated hearing devices (for example BAHA Soft Band, BAHA SoundArc, MED-EL Adhear, SoundBite) are not covered under plans that exclude hearing aids.
Exception and administrative notes: BAHA Soft Band, BAHA SoundArc or MED-EL Adhear may be covered as a bridge for children less than 5 years of age with conductive or mixed hearing loss who otherwise meet medical necessity criteria for an implantable BAHA. Coverage of accessories and upgrades requires a separate medical necessity assessment considering the member’s current device function and expected clinically significant benefit.
Supplemental: osseointegrated implants are treated as prosthetics per Medicare guidance; providers should check specific benefit plan descriptions for hearing-aid exclusions and coverage details.
| 69710 | Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone [temporal bone stimulator] [Audiant Bone Conductor] [Bonebridge Bone Conduction Implant] |
| 69711 | Removal or repair of electromagnetic bone conduction hearing device in temporal bone [temporal bone stimulator] [Audiant Bone Conductor] |
| 69714 | Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor/cochlear stimulator; without mastoidectomy [BAHA, Ponto Pro] |
| 69716 | Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor |
| 69717 | Replacement (including removal of existing device), osseointegrated implant, temporal bone, with percutaneous attachment to external speech processor; without mastoidectomy [BAHA, Ponto Pro] |
| 69719 | Revision or replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor |
| 69726 | Removal, osseointegrated implant, skull; with percutaneous attachment to external speech processor |
| 69727 | Removal, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor |
| 69728 | Removal, entire osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, outside the mastoid and involving a bony defect >= 100 sq mm |
| 69729 | Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, outside of the mastoid and resulting in removal of >= 100 sq mm bone |
| L8690 | Auditory osseointegrated device, includes all internal and external components [Otomag Alpha 1(M), Baha 5 superpower, Cochlear Osia B1300, Baha 6 Max] |
| L8691 | Auditory osseointegrated device, external sound processor, replacement [Otomag Alpha 1(M)] |
| L8692 | Auditory osseointegrated device, external sound processor, used without osseointegration, body worn, includes headband or other external attachment [excluded under plans that exclude hearing aids] [covered for under age 5] [Baha soft band, Baha SoundArc, MED-EL Adhear] |
| L8693 | Auditory osseointegrated device abutment, any length, replacement only [Otomag Alpha 1(M)] |
| L8694 | Auditory osseointegrated device, transducer/actuator, replacement only, each |
| G0153 | Services performed by a qualified speech-language pathologist in the home health or hospice setting, each 15 minutes |
| S9128 | Speech therapy, in the home, per diem |
| V5008 | Hearing services (range V5008-V5299) |
| C30.1 | Malignant neoplasm of middle ear |
| C44.201 | Other and unspecified malignant neoplasm of skin of ear and external auricular canal (range C44.201-C44.299) |
| C47.0 | Malignant neoplasm of peripheral nerves of head, face and neck |
| C49.0 | Malignant neoplasm of connective and soft tissue of head, face and neck |
| D04.20 | Carcinoma in situ of skin of ear and external auricular canal (range D04.20-D04.22) |
| D14.0 | Benign neoplasm of middle ear, nasal cavity and accessory sinuses |
| D21.0 | Benign neoplasm of connective and other soft tissue of head, face and neck |
| D22.20 | Melanocytic nevi of ear and external auricular canal (range D22.20-D22.22) |
| D23.20 | Other benign neoplasm of skin of ear and external auricular canal (range D23.20-D23.22) |
| H61.111 | Acquired deformity of pinna (range H61.111-H61.119) [surgically induced malformations] |
| H90.3 | Sensorineural hearing loss [other than unilateral] |
| H90.5 | Sensorineural hearing loss [other than unilateral] |
| Q78.0 | Osteogenesis imperfecta |
| H90.0 | Hearing loss (broad range H90.0-H93.93 listed as not covered for certain devices/SoundBite) |
| H90.A21 | Sensorineural hearing loss, unilateral, with restricted hearing on the contralateral side (listed under not covered for Otomag Alpha 1(M)) |
| H90.A22 | Sensorineural hearing loss, unilateral, with restricted hearing on the contralateral side (listed under not covered for Otomag Alpha 1(M)) |
| Bonebridge de novo (FDA July 2018) | Indications: age >= 12 years; conductive or mixed hearing loss with PTA BC <= 45 dB HL (0.5,1,2,3 kHz); bilateral fitting criteria (BC difference <10 dB avg or <15 dB at frequencies); single-sided deafness with AC PTA of hearing ear <=20 dB HL (0.5,1,2,3 kHz). |
| Cochlear Baha SoundArc (FDA 501(k) cleared June 7, 2017) | Indications: patients of any age with conductive or mixed hearing loss meeting BC PTA thresholds depending on processor model (<=45 dB HL for BP100, Baha 4/5; <=55 dB HL for BP110 Power/Baha 5 Power; <=65 dB HL for Cordelle II/Baha 5 SuperPower); bilateral fitting and SSD indications with AC PTA <=20 dB HL for normal hearing ear; symmetry definitions: <10 dB avg or <15 dB at individual frequencies. |
| Adhear (MED-EL) 510(k) | Indications: unilateral/bilateral conductive hearing loss with BC PTA <=25 dB HL (0.5,1,2,3 kHz); single-sided deafness with normal contralateral hearing defined as AC PTA <=20 dB HL (0.5,1,2,3 kHz). |
| Battery | Life expectancy = 72 per 6 months |
| Headband | Life expectancy = 1 per year |
| Processor | Life expectancy = 1 per 5 years |
| K984162 | Branemark Bone Anchored Hearing Aid (BAHA) System; FDA 510(k) Summary of Safety and Effectiveness; June 28, 1999 |
| K132278 | Cochlear Baha 4 Sound Processor; FDA 510(k); September 26, 2013 |
| K142907 | Cochlear Baha 5 Sound Processor; FDA 510(k); March 25, 2015 |
| K172460 | ADHEAR System Bone Conduction Hearing Prosthesis; FDA 510(k); April 27, 2018 |
| K090720 | BAHA BP100; FDA 510(k); June 17, 2009 |
| K080363 | BAHA Cordelle II; FDA 510(k); April 10, 2008 |
| K042017 | BAHA Divino; FDA 510(k); August 26, 2004 |
| K081606 | BAHA Intenso; FDA 510(k); August 28, 2008 |
| K011438 | Bilateral fitting of BAHA; FDA 510(k); July 23, 2001 |
| DEN170009 | Bonebridge Bone Conduction Hearing Implant; FDA De Novo; July 20, 2018 |
Document audiologic testing and reason air-conduction aids are contraindicated
Providers must document the member's age and detailed audiologic testing showing bone-conduction pure-tone average (PTA) and explain why a conventional air-conduction hearing aid is contraindicated. Required documentation should include age (implantation generally requires age ≥5), pre-implantation bone-conduction PTA, comparison/symmetry data for bilateral candidacy, and a clear clinical reason air-conduction aids cannot restore hearing (examples: congenital aural atresia, dermatitis/hypersensitivity to ear molds, otosclerosis when stapedectomy is not possible, severe chronic otitis, tumors of the external ear/tympanic cavity).
Verify device-specific audiometric thresholds
Document device-specific audiometric thresholds using bone-conduction PTA measured at the frequencies required by the device indication. Verify thresholds at 0.5, 1, 2 and 3 kHz and confirm that the BC PTA meets the processor/system-specific cutoff (device-dependent thresholds vary by model and power).
Assess candidacy for bilateral fitting
When assessing candidacy for bilateral fitting, document that bilateral bone-conduction thresholds are symmetric per policy definitions. Record side-to-side BC differences and confirm they meet the symmetric criteria appropriate for the device.
Document single-sided deafness (SSD) criteria
For single-sided deafness (SSD) indications, document the air-conduction pure tone average (AC PTA) of the better-hearing ear. The normal-hearing ear must meet the policy definition when required by the device: AC PTA ≤20 dB HL measured at 0.5, 1, 2, and 3 kHz.
Medical necessity review for accessories/upgrades
A separate assessment is required for medical necessity of recommended accessories and upgrades. Providers should document the member's current condition, how the current device performs, and the expected clinically significant benefit from the accessory or upgrade to support prior authorization.
Use applicable CPT/HCPCS/ICD-10 codes
Use the applicable CPT and HCPCS procedure and supply codes when selection criteria are met and include diagnosis codes that justify the medical indication. Report implantation, removal, revision, programming, and replacement with the listed codes.
Requests for non-covered devices/indications
Requests for certain devices or indications may be denied as experimental/investigational or not covered. Documented exceptions are limited; providers should be aware intra-oral devices (e.g., SoundBite), Otomag Alpha 1(M) and some partially implantable systems are considered experimental or not covered for broad indications and may be denied unless specific covered exceptions apply. Plans that exclude hearing aids do not cover non-osseointegrated devices except limited pediatric bridge uses.
Policy review dates and effective date
Document the policy's effective date and review schedule in the patient's record and cite the current policy version when submitting requests. Providers should reference the most recent policy for coverage criteria.
Background: A bone-anchored hearing aid (BAHA) is an osseointegrated bone-conduction hearing device that transmits sound through a titanium implant in the skull directly to the cochlea, bypassing the outer and middle ear. Typical device examples include BAHA and Ponto systems and newer active/transcutaneous systems such as Bonebridge, Cochlear Osia, Sophono/Otomag, SoundBite (intra-oral), and MED-EL Adhear.
Regulatory and evidence summary: The FDA has cleared BAHA devices for marketing for individuals aged 5 years and older for conductive or mixed hearing loss and for unilateral sensorineural deafness (SSD) based on 510(k)/De Novo submissions. The evidence base comprises multiple small clinical trials, case series, and systematic reviews showing audiologic benefit in conductive/mixed losses and SSD, though many studies are small, nonrandomized, or of limited duration.
| Evidence source | Summary |
|---|---|
| FDA clearance | |
| BAHA and multiple bone-conduction systems have FDA 510(k) and De Novo clearances for specific age and audiometric indications (e.g., BAHA systems, Bonebridge de novo July 2018, ADHEAR 510(k)). | |
| Clinical trials / studies | |
| Multiple small trials and case series report audiologic gains and quality-of-life benefits in conductive/mixed loss and SSD; many studies are small, nonrandomized (see Baguley 2006, Priwin 2007, de Wolf 2011). | |
| Key systematic reviews | |
| Systematic reviews and HTAs (e.g., Health Technol Assess. 2011; CADTH reports) summarize evidence supporting BAHA use but note limitations of study quality. | |
| Dimitriadis 2016 | |
| Systematic review of BAHA Attract: 10 studies, 89 cases; satisfactory functional and audiological results and low complication rate versus percutaneous devices; recommends further robust trials. | |
| Kiringoda & Lustig 2013 | |
| Meta-analysis of complications (20 articles, 2,134 patients): Holgers Grade 2-4 skin reactions 2.4%–38.1%; implant loss in adults 1.6%–17.4%; variable osseointegration failure and revision rates. | |
| Osia early series | |
| Small prospective/series (n≈9–10) report significant audiologic gains and QOL improvements with active Osia system; early results favorable. | |
| Ponto / Bonebridge / Attract device studies | |
| Comparative and device-specific studies (Ponto Pro, BAHA Attract, Bonebridge) show improved speech understanding and patient satisfaction in selected populations; Bonebridge de novo includes explicit audiometric/age criteria. | |
| Other device series and bench/preclinical data | |
| Preclinical and early clinical evaluations (e.g., Bonebridge, Huber 2013) indicate functional performance comparable to BAHA and support further clinical trials. |
Glossary — key definitions:
Symmetric bone conduction threshold: Either a ≤ 10 dB average difference between ears (device-specific frequency sets, e.g., 0.5, 1, 2 and 3 or 4 kHz) or <15 dB difference at individual frequencies.
Non-functional / non-amplifiable: Unilateral sensorineural hearing loss level at which conventional amplification is ineffective (used to define SSD BAHA candidacy).
PTA: Pure tone average measured at 0.5, 1, 2, and 3 kHz.
BC: Bone conduction.
AC: Air conduction.
SSD (Single-Sided Deafness): Profound sensorineural hearing loss in one ear with normal or near-normal hearing in the other ear (policy defines normal hearing for the contralateral ear as AC PTA ≤ 20 dB HL where specified).
| Name | Effective Date | Type/Number | Summary |
|---|---|---|---|
| {"text":"Hearing aids and auditory implants (Medicare Benefit Policy Manual Ch.16 Section 100)","status":""},{"text":"2005-11-10","status":""},{"text":"NCD (Rev.39; Issued: 11-10-05; Effective: 11-10-05)","status":""},{"text":"Medicare guidance (issued/effective 11-10-2005) addresses hearing aids and auditory implants; Aetna follows Medicare classification treating osseointegrated implants (implantable BAHAs and temporal bone stimulators) as prosthetics where applicable.","status":""} |
Policy effective date
Policy last reviewed
Scheduled next review date