Latest Review Date: March 2024

Category:  Surgery                                                                 

POLICY:

Unilateral or bilateral fully or partially implantable bone-conduction (bone-anchored) hearing aid(s) may be considered medically necessary as an alternative to an air-conduction hearing aid in individuals five years of age and older with a conductive or mixed hearing loss who also meet at least one of the following medical criteria:

• A pure tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (OBC and BP100 devices), 55 dB (Intenso device), or 65 dB (Cordele II device);  and one of the following:
  • Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear; or
  • Chronic external otitis or otitis media; or
  • Tumors of the external canal and/or tympanic cavity; or
  • Dermatitis of the external canal.

For bilateral implantation, individuals should meet the above audiologic criteria and have a symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz (4 kHz for OBC and Ponto Pro), or less than 15 dB at individual frequencies.

An implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction contralateral routing of signal hearing aid in individuals 5 years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.

Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in individuals with bilateral sensorineural hearing loss, is considered investigational and not medically necessary.

Non-osseointegrated hearing devices (e.g., BAHA Soft Band, SoundBite, Med-El Adhear) are not addressed in this medical policy since they are not osseointegrated. Please check benefit plan descriptions for hearing aid coverage.

Replacement for lost sound processors are non-covered. Individuals should contact the manufacturer for replacement under warranty or the manufacturer’s replacement policy.

Replacement or upgrade of existing properly functioning durable medical equipment (including prosthetics), even if the warranty has expired is a contract exclusion.*

*Always check benefits for self-funded groups as it relates to contract exclusions.

DESCRIPTION OF PROCEDURE OR SERVICE:

Sensorineural, conductive, and mixed hearing loss may be treated with a variety of devices, including conventional air-conduction (AC) or bone-conduction external hearing aids. AC hearing aids may be problematic in patients with chronic middle ear and ear canal infections, atresia of the external canal, or an ear canal that cannot accommodate an ear mold. Bone-conduction hearing aids may be useful for individuals with conductive hearing loss, or (if used with contralateral routing of signal), for unilateral sensorineural hearing loss. Implantable, bone-anchored hearing aids (BAHA) that use a percutaneous or transcutaneous connection to a sound processor have been investigated as alternatives to conventional bone-conduction hearing aids for patients with conductive or mixed hearing loss or in patients with unilateral single-sided sensorineural hearing loss.

Hearing Loss

Hearing loss is described as conductive, sensorineural, or mixed and can be unilateral or bilateral. Normal hearing is the detection of sound at or below 20 dB (decibel). The American Speech-Language-Hearing Association (ASLHA) has defined the degree of hearing loss based on pure-tone average (PTA) detection thresholds as mild (20 to 40 dB), moderate (40 to 60 dB), severe (60 to 80 dB), and profound (>80 dB). PTA is calculated by averaging the hearing sensitivities (i.e., the minimum volume that the patient hears) at multiple frequencies (perceived as pitch), typically within the range of 0.25 to 8 kHz.

Sound amplification through the use of an air-conduction (AC) hearing aid can provide benefit to patients with sensorineural or mixed hearing loss. Contralateral routing of signal (CROS) is a system in which a microphone on the affected side transmits a signal to an air-conduction hearing aid on the normal or less affected side.

Treatment

External bone-conduction hearing aids function by transmitting sound waves through the bone to the ossicles of the middle ear. The external devices must be closely applied to the temporal bone, with either a steel spring over the top of the head or with the use of a spring-loaded arm on a pair of spectacles. These devices may be associated with either pressure headaches or soreness.

A bone-anchored implant system works by combining a vibrational transducer coupled directly to the skull via a percutaneous abutment that permanently protrudes through the skin from a small titanium implant anchored in the temporal bone. The system is based on the process of osseointegration through which living tissue integrates with titanium in the implant over a period of 3 to 6 months, allowing amplified and processed sound to be conducted via the skull bone directly to the cochlea. The lack of intervening skin permits the transmission of vibrations at a lower energy level than required for external bone-conduction hearing aids. Implantable bone-conduction hearing systems are primarily indicated for people with conductive or mixed sensorineural/conductive hearing loss. However, they may also be used with CROS as an alternative to an AC hearing aid with CROS for individuals with unilateral sensorineural hearing loss.

Partially implantable magnetic bone-conduction hearing system, also referred to as transcutaneous bone-anchored systems, are available as an alternative to bone-conduction hearing systems connected percutaneously via an abutment. With this technique, acoustic transmission occurs transcutaneously via magnetic coupling of the external sound processor and the internally implanted device components. The bone-conduction hearing processor contains magnets that adhere externally to magnets implanted in shallow bone beds with the bone-conduction hearing implant. Since the processor adheres magnetically to the implant, there is no need for a percutaneous abutment to physically connect the external and internal components. To facilitate greater transmission of acoustics between magnets, skin thickness may be reduced to 4 to 5 mm over the implant when it is surgically placed.

KEY POINTS:

The most recent literature update was performed through December 22, 2023.

Summary of Evidence

For individuals who have conductive or mixed hearing loss who receive an implantable BAHA with a percutaneous abutment or a partially implantable BAHA with transcutaneous coupling to the sound processor, the evidence includes observational studies that have reported pre-post differences in hearing parameters after treatment with BAHAs. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. No prospective trials were identified. Observational studies reporting on within-subjects changes in hearing have generally reported hearing improvements with the devices. Given the objectively measured outcomes and the largely invariable natural history of hearing loss in individuals who would be eligible for an implantable bone-conduction device, the demonstrated improvements in hearing after device placement can be attributed to the device. Studies of partially implantable BAHAs have similarly demonstrated within-subjects improvements in hearing. The single-arm studies have shown improvements in hearing in the device-aided state. No direct comparisons other than within-individual comparisons with external hearing aids were identified, but, for individuals unable to wear an external hearing aid, there may be few alternative treatments. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have unilateral sensorineural hearing loss who receive a fully or partially implantable BAHA with the contralateral routing of signal, the evidence includes an RCT, multiple prospective and retrospective case series, and a systematic review. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. Single-arm case series, with sample sizes ranging from 9 to 180 patients, have generally reported improvements in patient-reported speech quality, speech perception in noise, and satisfaction with bone-conduction devices with contralateral routing of the signal. However, a well-conducted systematic review of studies comparing bone-anchored devices with hearing aids using contralateral routing of signal found no evidence of improvement in speech recognition or hearing localization. The single RCT included in the systematic review was a pilot study enrolling only 10 patients and, therefore, does not provide definitive evidence. Quality RCTs on BAHA for unilateral sensorineural hearing loss are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Otolaryngology-Head and Neck Surgery

In 2021, the American Academy of Otolaryngology-Head and Neck Surgery updated its position statement on the use of implantable hearing devices. It states that the Academy “considers bone conduction hearing devices (BCHD) as appropriate, and in some cases preferred, for the treatment of conductive and mixed hearing loss. BCHD may also be indicated in select patients with single-sided deafness. BCHD include semi-implantable bone conduction devices utilizing either a percutaneous or transcutaneous attachment, as well as bone conduction oral appliances and scalp-worn devices. The recommendation for BCHD should be determined by a qualified otolaryngology-head and neck surgeon. These devices are approved by the Food and Drug Administration (FDA) for these indications, and their use should adhere to the restrictions and guidelines specified by the appropriate governing agency, such as the FDA in the United States and the respective regulatory agencies in countries other than the United States."

U.S. Preventative Services Task Force Recommendations

Not applicable.

KEY WORDS:

Bone conduction hearing aid, bone-anchored hearing aid (BAHA), implantable bone conduction hearing aid, air conduction hearing aid, single-sided deafness, and hearing aid, Otomag Sophono, partially implantable hearing aid, BAHA 4 Attract, BoneBridge™, BA310 Abutment, BIA 310 Implant/Abutment, Bonebridge, Baha 5 Super Power Sound Processor, Ponto 3, Ponto 4, OSIA bone conduction hearing system, Cochlear Osia, Cochlear™ Osia® 2 System, Osia OSI200 Implant

APPROVED BY GOVERNING BODIES:

Several implantable bone-conduction hearing systems have been approved by the US Food and Drug Administration for marketing through the 510(k) process (Table 1).

Table 1. Implantable Bone-Conduction Hearing Systems Approved by the U.S Food and Drug Administration

Device	Manufacturer	Date Cleared	510(k) No.
Baha 6 System	Cochlear Americas	Sept 2021	K212136
BA310 Abutment, BIA310 Implant/Abutment		Dec 2018	K182116
Baha 5 Power Sound Processor		May 2016	K161123
Baha 5 Super Power Sound Processor		Mar 2016	K153245
Baha® 5 Sound Processor		Mar 2015	K142907
Baha® Attract System		Nov 2013	K131240
Baha® Cordelle II		Jul 2015 Apr 2008	K150751 K080363
Baha Divino®		Aug 2004	K042017
Baha Intenso® (digital signal processing)		Aug 2008	K081606
Baha® 4 (upgraded from the BP100)		Sep 2013	K132278
Cochlear™ Osia™2 System		Dec 2019	K191921
OBC Bone-Anchored Hearing Aid System	Oticon Medical	Nov 2011	K112053
Ponto Bone-Anchored Hearing System	Oticon Medical	Sep 2012	K121228
Ponto 5 SuperPower	Oticon Medical	Dec 2021	K213733
Ponto 4		May 2019	K190540
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower		Sep 2016	K161671

The FDA cleared these systems for use in children age 5 years and older and adults for the following indications:

• Patients who have conductive or mixed hearing loss and can still benefit from sound amplification;

• Patients with bilaterally symmetric conductive or mixed hearing loss may be implanted bilaterally;

• Patients with sensorineural deafness in 1 ear and normal hearing in the other (i.e., single-sided deafness);

 • Patients who are candidates for an AC CROS hearing aid but who cannot or will not wear an AC CROS device.

Baha sound processors can be used with the Baha® Softband™. With this application, there is no implantation surgery. The sound processor is attached to the head using a hard or soft headband. The amplified sound is transmitted transcutaneously to the cochlea via the bones of the skull. In 2002, the Baha Softband was cleared for marketing by FDA for use in children younger than 5 years. Because this application has no implanted components, it is not addressed in this evidence review.

The FDA also cleared two partially implantable magnetic bone-conduction devices for marketing through the 510(k) process (Table 2) .

Table 2. Partially Implantable Magnetic Bone-Conduction Devices Approved by the U.S Food and Drug Administration

 

Device	Manufacturer	Date Cleared	510(k) No.
Bonebridge	MED-EL	Mar 2019	K183373
Otomag® Bone-Conduction Hearing System	Medtronic (Formerly Sophono)	Nov 2013	K132189
Cochlear Baha® 4 Sound Processor	Cochlear Americas	Oct 2012	K121317

The SoundBite™ Hearing System (Sonitus Medical, San Mateo, CA) is an intraoral bone-conducting hearing prosthesis that consists of a behind-the-ear microphone and an in-the-mouth hearing device. In 2011, it was cleared for marketing by FDA through the 510(k) process for indications similar to the Baha. However, the manufacturer, Sonitus Medical, closed in 2015.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT codes:    

69710	Implantation or replacement of electromagnetic bone-conduction hearing device in temporal bone
69711	Removal or repair of electromagnetic bone-conduction hearing device in temporal bone
69714	Implantation, osseointegrated implant, skull; with percutaneous attachment to external speech processor
69716	Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or resulting in removal of less than 100 sq mm surface area of bone deep to the outer cranial cortex  (Effective 01/01/22)
69717	Replacement (including removal of existing device), osseointegrated implant, skull; with percutaneous attachment to external speech processor
69719	Replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or involving a bony defect less than 100 sq mm surface area of bone deep to the outer cranial cortex (Effective 01/01/22)
69726	Removal, entire osseointegrated implant, skull; with percutaneous attachment to external speech processor
69727	Removal, entire osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or involving a bony defect less than 100 sq mm surface area of bone deep to the outer cranial cortex
69728	Removal, osseointegrated implant, skull; with attachment to external speech processor, outside the mastoid (Effective 01/01/23)
69729	Implantation, osseointegrated implant, skull; with  attachment to external speech processor, outside of the mastoid (Effective 01/01/23)
69730	Replacement osseointegrated implant, skull; with attachment to external speech processor, outside the mastoid (Effective 01/01/23)
92622	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes
92623	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; each additional 15 minutes (List separately in addition to code for primary procedure)
92626	Evaluation of auditory function for surgically implanted device(s) candidacy or postoperative status of a surgically implanted device(s); first hour
92627	; each additional 15 minutes (list separately in addition to code for primary procedure)

HCPCS Codes:

L8625	External recharging system for battery for use with cochlear implant or auditory osseointegrated device, replacement only, each
L8690	Auditory osseointegrated device, includes all internal and external components
L8691	Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each
L8693	Auditory osseointegrated device abutment, any length, replacement only
L8694	Auditory osseointegrated device, transducer/actuator, replacement only, each

REFERENCES:

1. AlFarraj A, AlIbrahim M, AlHajjaj H, et al. Transcutaneous Bone Conduction Implants in Patients With Single-SidedDeafness: Objective and Subjective Evaluation. Ear Nose Throat J. May 02 2022: 1455613221099996.
2. Allis TJ, Owen BD, Chen B, et al. Longer length Baha abutments decrease wound complications and revision surgery. Laryngoscope. Apr 2014; 124(4):989-992.
3. American Academy of Otolaryngology-Head and Neck Surgery. Implantable Hearing Devices. Position Statements 2013; //www.entnet.org/?q=node/932.
4. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Bone Conduction Hearing Devices.Position Statements 2016; www.entnet.org/resource/position-statement-bone-conduction-hearing-devices/.
5. Amonoo-Kuofi K, Kelly A, Neeff M, et al. Experience of bone-anchored hearing aid implantation in children younger than 5 years of age. Int J Pediatr Otorhinolaryngol. Apr 2015; 79(4):474-480.
6. Baker S, Centric A, Chennupati SK. Innovation in abutment-free bone-anchored hearing devices in children: Updated results and experience. Int J Pediatr Otorhinolaryngol. Oct 2015; 79(10):1667-1672.
7. Bravo-Torres S, Der-Mussa C, Fuentes-Lopez E. Active transcutaneous bone conduction implant: audiological results in paediatric patients with bilateral microtia associated with external auditory canal atresia. Int J Audiol. Jan 2018; 57(1):53-60.
8. Briggs R, Van Hasselt A, Luntz M, et al. Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. Jun 2015; 36(5):834-841.
9. Calvo Bodnia N, Foghsgaard S, Nue Moller M, et al. Long-term Results of 185 Consecutive Osseointegrated Hearing Device Implantations: A Comparison Among Children, Adults, and Elderly. Otol Neurotol. Dec 2014; 35(10):e301-306.
10. Carnevale C, Morales-Olavarría C, Til-Pérez G, et al. Bonebridge ® bone conduction implant. Hearing outcomes and quality of life inpatients with conductive/mixed hearing loss. Eur Arch Otorhinolaryngol. Sep 05 2022.
11. Carnevale C, Morales-Olavarría C, Til-Pérez G, et al. Bonebridge ® bone conduction implant. Hearing outcomes and quality of life in patients with conductive/mixed hearing loss. Eur Arch Otorhinolaryngol. Apr 2023; 280(4): 1611-1619.
12. Carr SD, Moraleda J, Procter V, et al. Initial UK experience with a novel magnetic transcutaneous bone conduction device. Otol Neurotol. Sep 2015; 36(8):1399-1402.
13. Centric A, Chennupati SK. Abutment-free bone-anchored hearing devices in children: initial results and experience. Int J Pediatr Otorhinolaryngol. May 2014; 78(5):875-878.
14. Colquitt JL, Jones J, Harris P et al. Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation. Health Technol Assess 2011; 15(26):1-200, iii-iv.
15. Colquitt JL, Loveman E, Baguley DM et al. Bone-anchored hearing aids for people with bilateral hearing impairment: a systematic review. Clin Otolaryngol 2011; 36(5):419-41.
16. Cywka KB, Skarzynski PH, Krol B, et al. Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy andstability of audiological, surgical, and functional outcomes. Eur Arch Otorhinolaryngol. Jul 2022; 279(7): 3525-3534.
17. den Besten CA, Harterink E, McDermott AL, et al. Clinical results of Cochlear BIA300 in children: Experience in two tertiary referral centers. Int J Pediatr Otorhinolaryngol. Dec 2015; 79(12):2050-2055.
18. den Besten CA, Monksfield P, Bosman A, et al. Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study. Clin Otolaryngol. Oct 25 2018.
19. Denoyelle F, Coudert C, Thierry B, et al. Hearing rehabilitation with the closed skin bone-anchored implant Sophono Alpha1: results of a prospective study in 15 children with ear atresia. Int J Pediatr Otorhinolaryngol. Mar 2015; 79(3):382-387.
20. Desmet J, Wouters K, De Bodt M, et al. Long-term subjective benefit with a bone conduction implant sound processor in 44 patients with single-sided deafness. Otol Neurotol. Jul 2014; 35(6):1017-1025.
21. Dimitriadis PA, Farr MR, Allam A, et al. Three year experience with the cochlear BAHA Attract implant: a systematic review of the literature. BMC Ear Nose Throat Disord. 2016; 16:12.
22. Dun CA, Faber HT, de Wolf MJ et al. Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival. Otol Neurotol 2012; 33(2):192-8.
23. Farnoosh S, Mitsinikos FT, Maceri D, et al. Bone-Anchored Hearing Aid vs. Reconstruction of the External Auditory Canal in Children and Adolescents with Congenital Aural Atresia: A Comparison Study of Outcomes. Front Pediatr. 2014; 2:5.
24. Fontaine N, Hemar P, Schultz P, et al. BAHA implant: implantation technique and complications. Eur Ann Otorhinolaryngol Head Neck Dis. Feb 2014; 131(1):69-74.
25. Gawęcki W, Gibasiewicz R, Marszał J, et al. The evaluation of a surgery and the short-term benefits of a new active bone conductionhearing implant - the Osia®. Braz J Otorhinolaryngol. 2022; 88(3): 289-295.
26. Gerdes T, Salcher RB, Schwab B, et al. Comparison of audiological results between a transcutaneous and a percutaneous bone conduction instrument in conductive hearing loss. Otol Neurotol. Jul 2016; 37(6):685-691.
27. Gluth MB, Eager KM, Eikelboom RH et al. Long-term benefit perception, complications, and device malfunction rate of bone-anchored hearing aid implantation for profound unilateral sensorineural hearing loss. Otol Neurotol 2010; 31(9):1427-34.
28. Heath E, Dawoud MM, Stavrakas M, et al. The outcomes of bilateral bone conduction hearing devices (BCHD) implantation in thetreatment of hearing loss: A systematic review. Cochlear Implants Int. Mar 2022; 23(2): 95-108.
29. Hill-Feltham P, Roberts SA, Gladdis R. Digital processing technology for bone-anchored hearing aids: randomised comparison of two devices in hearing aid users with mixed or conductive hearing loss. J Laryngol Otol. Feb 2014; 128(2):119-127.
30. Hol MK, Nelissen RC, Agterberg MJ et al. Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. Otol Neurotol 2013; 34(6):1071-5.
31. Huber AM, Strauchmann B, Caversaccio MD, et al. Multicenter Results With an Active Transcutaneous Bone Conduction Implant inPatients With Single-sided Deafness. Otol Neurotol. Feb 01 2022; 43(2): 227-235.
32. Hultcrantz M, Lanis A. A five-year follow-up on the osseointegration of bone-anchored hearing device implantation without tissue reduction. Otol Neurotol. Sep 2014; 35(8):1480-1485.
33. Hundertpfund J, Meyer JE, Ovari A. Long-term audiological benefit with an active transcutaneous bone-conduction device: aretrospective cohort analysis. Eur Arch Otorhinolaryngol. Jul 2022; 279(7): 3309-3326.
34. Ihler F, Volbers L, Blum J, et al. Preliminary functional results and quality of life after implantation of a new bone conduction hearing device in patients with conductive and mixed hearing loss. Otol Neurotol. Feb 2014; 35(2):211-215.
35. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
36. Iseri M, Orhan KS, Kara A, et al. A new transcutaneous bone anchored hearing device - the Baha(R) Attract System: the first experience in Turkey. Kulak Burun Bogaz Ihtis Derg. Mar-Apr 2014; 24(2):59-64.
37. Iseri M, Orhan KS, Tuncer U, et al. Transcutaneous bone-anchored hearing aids versus percutaneous ones: multicenter comparative clinical study. Otol Neurotol. Jun 2015; 36(5):849-853.
38. Janssen RM, Hong P, Chadha NK. Bilateral bone-anchored hearing aids for bilateral permanent conductive hearing loss: a systematic review. Otolaryngol Head Neck Surg 2012; 147(3):412-22.
39. Kim Y, Choe G, Oh H, et al. A comparative study of audiological outcomes and compliance between the Osia system and other boneconduction hearing implants. Eur Arch Otorhinolaryngol. Nov 01 2022.
40. Kim Y, Choe G, Oh H, et al. A comparative study of audiological outcomes and compliance between the Osia system and other bone conduction hearing implants. Eur Arch Otorhinolaryngol. May 2023; 280(5): 2217-2224.
41. Kiringoda R, Lustig LR. A meta-analysis of the complications associated with osseointegrated hearing aids. Otol Neurotol 2013; 34(5):790-4.
42. Kompis M, Kurz A, Pfiffner F, et al. Is complex signal processing for bone conduction hearing aids useful? Cochlear Implants Int. May 2014; 15 Suppl 1:S47-50.
43. Kraai T, Brown C, Neeff M, et al. Complications of bone-anchored hearing aids in pediatric patients. Int J Pediatr Otorhinolaryngol. Jun 2011; 75(6):749-753.
44. Larsson A, Tjellstrom A, Stalfors J. Implant Losses for the Bone-Anchored Hearing Devices Are More Frequent in Some Patients. Otol Neurotol. May 7 2014.
45. Laske RD, Roosli C, Pfiffner F, et al. Functional results and subjective benefit of a transcutaneous bone conduction device in patients with single-sided deafness. Otol Neurotol. Aug 2015; 36(7):1151-1156.
46. Leterme G, Bernardeschi D, Bensemman A, et al. Contralateral routing of signal hearing aid versus transcutaneous bone conduction in single-sided deafness. Audiol Neurootol. 2015; 20(4):251-260.
47. Magliulo G, Turchetta R, Iannella G, et al. Sophono Alpha System and subtotal petrosectomy with external auditory canal blind sac closure. Eur Arch Otorhinolaryngol. Sep 2015; 272(9):2183-2190.
48. Manrique M, Sanhueza I, Manrique R, et al. A new bone conduction implant: surgical technique and results. Otol Neurotol. Feb 2014; 35(2):216-220.
49. Marsella P, Scorpecci A, Pacifico C et al. Pediatric BAHA in Italy: the "Bambino Gesu" Children's Hospital's experience. Eur Arch Otorhinolaryngol 2012; 269(2):467-74.
50. Marsella P, Scorpecci A, Vallarino MV, et al. Sophono in Pediatric Patients: The Experience of an Italian Tertiary Care Center. Otolaryngol Head Neck Surg. Apr 8 2014; 151(2):328-332.
51. Mohamad S, Khan I, Hey SY, et al. A systematic review on skin complications of bone-anchored hearing aids in relation to surgical techniques. Eur Arch Otorhinolaryngol. Dec 14 2014.
52. Monini S, Musy I, Filippi C, et al. Bone conductive implants in single-sided deafness. Acta Otolaryngol. Apr 2015; 135(4):381-388.
53. Nelissen RC, Agterberg MJ, Hol MK, et al. Three-year experience with the Sophono in children with congenital conductive unilateral hearing loss: tolerability, audiometry, and sound localization compared to a bone-anchored hearing aid. Eur Arch Otorhinolaryngol. Oct 2016; 273(10):3149-3156.
54. Nelissen RC, Stalfors J, de Wolf MJ, et al. Long-term stability, survival, and tolerability of a novel osseointegrated implant for bone conduction hearing: 3-year data from a multicenter, randomized, controlled clinical investigation. Otol Neurotol. Sep 2014; 35(8):1486-1491.
55. Nicolas S, Mohamed A, Yoann P et al. Long-term benefit and sound localization in patients with single-sided deafness rehabilitated with an osseointegrated bone-conduction device. Otol Neurotol 2013; 34(1):111-4.
56. O'Niel MB, Runge CL, Friedland DR, et al. Patient Outcomes in Magnet-Based Implantable Auditory Assist Devices. JAMA Otolaryngol Head Neck Surg. Apr 24 2014.
57. Pai I, Kelleher C, Nunn T et al. Outcome of bone-anchored hearing aids for single-sided deafness: a prospective study. Acta Otolaryngol 2012; 132(7):751-5.
58. Peters JP, Smit AL, Stegeman I, et al. Review: Bone conduction devices and contralateral routing of sound systems in single-sided deafness. Laryngoscope. Aug 14 2014.
59. Powell HR, Rolfe AM, Birman CS. A comparative study of audiologic outcomes for two transcutaneous bone-anchored hearing devices. Otol Neurotol. Sep 2015; 36(9):1525-1531.
60. Rahne T, Seiwerth I, Gotze G, et al. Functional results after Bonebridge implantation in adults and children with conductive and mixed hearing loss. Eur Arch Otorhinolaryngol. Nov 2015; 272(11):3263-3269.
61. Ramakrishnan Y, Marley S, Leese D, et al. Bone-anchored hearing aids in children and young adults: the Freeman Hospital experience. J Laryngol Otol. Feb 2011; 125(2):153-157.
62. Rebol J. Soft tissue reactions in patients with bone anchored hearing aids. Ir J Med Sci. Jun 10 2014.
63. Reddy-Kolanu R, Gan R, Marshall AH. A case series of a magnetic bone conduction hearing implant. Ann R Coll Surg Engl. Nov 2016; 98(8):552-553.
64. Riss D, Arnoldner C, Baumgartner WD, et al. Indication criteria and outcomes with the Bonebridge transcutaneous bone-conduction implant. Laryngoscope. Dec 2014; 124(12):2802-2806.
65. Roplekar R, Lim A, Hussain SS. Has the use of the linear incision reduced skin complications in bone-anchored hearing aid implantation? J Laryngol Otol. Jun 2016; 130(6):541-544.
66. Schmerber S, Deguine O, Marx M, et al. Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. Jul 30 2016.
67. Schwab B, Wimmer W, Severens JL, et al. Adverse events associated with bone-conduction and middle-ear implants: a systematic review. Eur Arch Otorhinolaryngol. Feb 2020; 277(2): 423-438.
68. Seiwerth I, Fröhlich L, Schilde S, et al. Clinical and functional results after implantation of the bonebridge, a semi-implantable, activetranscutaneous bone conduction device, in children and adults. Eur Arch Otorhinolaryngol. Jan 2022; 279(1): 101-113.
69. Siegert R. Partially implantable bone conduction hearing aids without a percutaneous abutment (Otomag): technique and preliminary clinical results. Adv Otorhinolaryngol 2011; 71:41-6.
70. Šikolová S, Urík M, Hošnová D, et al. Two Bonebridge bone conduction hearing implant generations: audiological benefit and quality ofhearing in children. Eur Arch Otorhinolaryngol. Jul 2022; 279(7): 3387-3398.
71. Snapp HA, Holt FD, Liu X, et al. Comparison of speech-in-noise and localization benefits in unilateral hearing loss subjects using contralateral routing of signal hearing aids or bone-anchored implants. Otol Neurotol. Jan 2017; 38(1):11-18.
72. Verheij E, Bezdjian A, Grolman W, et al. A systematic review on complications of tissue preservation surgical techniques in percutaneous bone conduction hearing devices. Otol Neurotol. Aug 2016; 37(7):829-837.
73. Zeitler DM, Snapp HA, Telischi FF et al. Bone-anchored implantation for single-sided deafness in patients with less than profound hearing loss. Otolaryngol Head Neck Surg 2012; 147(1):105-11.

POLICY HISTORY:

Medical Policy Group, November 2003 (1)

Medical Policy Administration Committee, December 2003

Available for comment January 13-February 26, 2004

Medical Policy Group, March 2005

Medical Policy Group, April 2005 (2)

Medical Policy Administration Committee, April 2005

Available for comment, April 25-June 8, 2006

Medical Policy Group, August 2007 (2)

Medical Policy Administration Committee, August 2007

Available for comment August 25-October 8, 2007

Medical Policy Group, November 2007 (2)

Medical Policy Administration Committee, December 2007

Available for comment December 8, 2007-January 21, 2008

Medical Policy Group, April 2008 (2)

Medical Policy Administration Committee, May 2008

Medical Policy Group, December 2009 (2)

Medical Policy Administration Committee, February 2010

Coding update December 2010 (1): 2011 Code update-added L8693

Medical Policy Group, June 2012 (4): Updated policy section to include Otomag Alpha 1 [M]), partially implantable hearing aid, updated Description, Key Points, Approved by Governing Bodies, Key Words and References..

Medical Policy Administration Committee, June 2012.

Available for comment June 26 through August 10, 2012

Medical Policy Panel, January 2013

Medical Policy Group, March 2013 (2): Deleted coverage criteria effective prior to 2007. Current criteria remain unchanged. Key Points and References updated.

Medical Policy Group, August 2013 (2): Added language for coverage of replacement upgraded processors.

Medical Policy Administration Committee August 2013

Available for comment August 22 through October 5, 2013

Medical Policy Group, May 2014 (5):  Updated policy section to include BAHA 4 Attract, partially implantable magnetic bone-conduction hearing system.  Updated Description, Key Points, Approved by Governing Bodies, Key Words and References.

Medical Policy Administration Committee June 2014

Available for comment May 30 through July 13, 2014

Medical Policy Group, June 2014 (5):  Removed BAHA 4 Attract and partially implantable magnetic bone-conduction hearing system from policy statement.  Removed partially implantable magnetic bone-conduction hearing system from description, key points, and approved by Governing Bodies. 

Medical Policy Administration Committee July 2014

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (6):  2015 Updates to Description, Key Points, Approved by Governing Bodies, and References; no change to policy statement

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Updates to Description, Key Points, Key Words, Approved by Governing Bodies, Coding (added codes 69710 and 69711) and References; no changes to policy statement.

Medical Policy Panel, July 2016

Medical Policy Group, August 2016 (6): Updates to Summary and References. Removed Otomag Alpha 1 from policy statement, added fully or partially implantable in policy statement.

Medical Policy Group, September 2016 (6): Updated replacement verbiage in policy statement, no change to policy intent.

Medical Policy Group, October 2016 (6): Removed L8692 from coding section.

Medical Policy Administration Committee, October 2016

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (6): Updates to Key Points, Position Statements and References.

Medical Policy Group, December 2017: Annual Coding Update  2018.  Added new HCPCS code L8694 to Current Coding. Updated verbiage for revised code L8691.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points and Coding. No change to policy statement.

Medical Policy Panel, February 2019

Medical Policy Group, March 2019 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Group, May 2019 (6): Added clarification statement Non-osseointegrated hearing devices (e.g., BAHA Soft Band, SoundBite, Med-El Adhear) are not addressed in this medical policy since they are not osseointegrated. Please check benefit plan descriptions for hearing aid coverage.

Medical Policy Group, August 2019 (6): Updated Policy statement to include non-coverage for lost sound processors.

Medical Policy Group, December 2019 (6): 2020 Annual Coding Update, added 92626-92627.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points, Governing Bodies and Key Words (BA310 Abutment, BIA 310 Implant/Abutment, Bonebridge, Baha 5 Super Power Sound Processor, Ponto 3, Ponto 4).

Medical Policy Panel, February 2021

Medical Policy Group, March 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements and References. Policy statement updated to remove “not medically necessary, “no other changes to policy statement or intent.

Medical Policy Group, June 2021 (3): Minor Updates to Key Words and Approved By Governing Bodies. Key Words added: Cochlear Osia, Cochlear™ Osia® 2 System, Osia OSI200 Implant. No other changes to policy statement or intent.

Medical Policy Group, December 2021(3):  2022 Annual Coding Update.  Added CPT codes 69716 and 69719 to the Current coding section. Created Previous Coding section to include codes 69715 and 69718 which will be deleted as of 12/31/21. Revised CPT codes 69714 and 69717 to state: For 69714 “temporal bone” replaced with “skull”. “cochlear stimulator” and “without mastoidectomy” also removed. For 69717 in addition to the changes to 69714, added that 69717 could be used for a revision in addition to a replacement.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (3): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, November 2022 (6) 2023 Annual Coding Update. Added CPT codes 69728, 69729, 69730 to Current Coding section. Revised CPT codes 69716, 69717, 69719, 69726, 69727.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (6): Updates to Key Points, Practice Guidelines, Benefit Application and References.

Medical Policy Group, February 2023: 2024 Annual Coding Update. Added codes 92622 and 92623 to the Current Coding section.

Medical Policy Panel, February 2024

Medical Policy Group, March 2024 (9): Minor updates to Key Points, Benefit Application, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.