Conventional external hearing aids can be categorized as air conduction (AC) hearing aids or bone conduction (BC) hearing aids. An implantable bone conduction hearing aid, also called a bone-anchored hearing aid (BAHA^®) (Cochlear Americas, Centennial, CO and Cochlear Limited Bone Anchored Solutions AB, Mölnlycke, Sweden), functions by using a skin penetrating titanium implant that transmits sound waves to the cochlea through the skull bone. A transcutaneously worn, nonsurgical application of the BAHA is a bone conduction-type hearing aid which utilizes a Headband or Softband. The Headband/Softband consists of an elastic band with a plastic disc-like snap connector sewn into the band. A BAHA sound process is attached to the plastic connector and adjusted to the size of the individual's head, secured with a Velcro^® fastener (Velcro USA Inc., Manchester, NH).

This document addresses the use of the BAHA^®_, a U.S. Food and Drug Administration (FDA) approved implantable or transcutaneously worn bone conduction hearing aid as an alternative to an air conduction hearing aid in the treatment of moderate-to-severe hearing loss (HL), or, to improve speech recognition in individuals with unilateral sensorineural hearing loss, also referred to as single sided deafness (SSD™).

Note: Please see the following documents related to implants and hearing aids for the treatment of hearing loss:

• SURG.00014 Cochlear Implants and Auditory Brainstem Implants
• SURG.00084 Implantable Middle Ear Hearing Aids

Note: Benefit language supersedes this document. Hearing aids are not a covered benefit under all member contracts/certificates. Please see the text in the footnote of this document regarding Federal and State mandates and contract language, as these requirements or documents may specifically address the topic of hearing aids.

Medically Necessary:

An implantable bone-anchored hearing aid is considered medically necessary for individuals who meet the criteria specified in either (A) or (B), below.

1. An implantable bone-anchored hearing aid is considered medically necessary as an alternative to an air conduction hearing aid for individuals five years of age and older who meet both audiologic and medical condition criteria as follows:
   1. Audiologic criteria (must meet one):
      • Bilateral implant: Moderate to severe bilateral symmetric bone conductive or mixed (conductive and sensorineural) hearing loss. Symmetric bone conduction threshold is defined as less than:
        1. 10 decibels (dB) average difference between ears (measured at 0.5, 1, 2, and 4 kilohertz [kHz]), or less than a 15 dB difference at individual frequencies (BAHA Divino™); or
        2. 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies (BAHA Cordelle II; BAHA BP100; BAHA Intenso™); OR 
      • Unilateral implant: Conductive or mixed (conductive and sensorineural) hearing loss with pure tone average (PTA) bone conduction hearing threshold better than or equal to 45 dB hearing loss (HL) (BAHA Divino, BAHA BP100), 55 dB HL (BAHA Intenso), or 65 dB HL (BAHA Cordelle II).
   2. Medical condition criteria (must meet at least one):
      • Congenital or surgically induced ear malformations of the external or middle ear canal (e.g., atresia);  or
      • Severe chronic external otitis or otitis media; or
      • Tumors of the external ear canal or tympanic cavity; or
      • Dermatitis of the external ear canal, including reactions from ear molds used in air conduction hearing aids; or
      • Other anatomic or medical conditions that contraindicate the use of an air conduction hearing aid. 
2. An implantable bone-anchored hearing aid is considered medically necessary to improve speech recognition in individuals five years of age and older with unilateral sensorineural hearing loss (i.e. single sided deafness) while the other ear has normal hearing. Normal hearing is defined as PTA air conduction (AC) threshold equal to or better than 20 dB HL at 0.5, 1, 2, and 3 kHz.
3. A transcutaneously worn BAHA (bone conduction-type hearing aid) utilizing a Headband or Softband is considered medically necessary as an alternative to an implantable bone anchored hearing aid or air conduction hearing aid in individuals who meet the criteria specified in either (A) or (B), above, except for the age limitation of 5 years of age and older which does not apply for a transcutaneously worn BAHA.      

Replacement parts or upgrades to existing BAHA components (e.g. batteries, processor, or Headband/Softband) are considered medically necessary for individuals whose response to existing components is inadequate to the point of interfering with activities of daily living or when components are no longer functional.

Not Medically Necessary

Replacement parts or upgrades to existing BAHA components (e.g. batteries, processor, or Headband/Softband) are considered not medically necessary when the criteria specified in (A) or (B) or (C) above are not met or when requested for convenience or to upgrade to newer technology when the current components remains functional. 

Investigational and Not Medically Necessary:

An implantable bone-anchored hearing aid or a transcutaneously worn bone conduction-type hearing aid utilizing a Headband or Softband is considered investigational and not medically necessary for all other indications when the above criteria are not met.

BAHA for Moderate to Severe Conductive or Mixed Hearing Loss

The medical literature contains numerous prospective and retrospective clinical trials that evaluate the safety and efficacy of an implanted bone-anchored hearing aid for moderate to severe conductive or mixed hearing loss. Participants in these studies usually received unilateral hearing aids. The early studies of the BAHA (Granstrom, 1997 and 2001; Hakansson, 1990 and 1994) were reported by the BAHA implant programs at the Sahlgrenska Hospital at the University of Göteborg, Sweden (where the BAHA was originally developed); the Nijmegen University Hospital, The Netherlands (Snik, 1995 and 2001; Stenfelt, 2000; van der Pouw, 1998 and 1999); and the Birmingham Osseointegration Program (The Queen Elizabeth, Selly Oak, and Birmingham Children's Hospitals, Birmingham, UK) (Dutt, 2002 [multiple studies]; McDermott, 2002, two studies; McLarnon, 2004). Results from each of the centers are reported in multiple articles with overlapping study populations. The authors suggest that the BAHA can provide significant improvements in functional gain, speech perception, and hearing ability in various listening situations. User satisfaction was also reported in self-assessed outcomes measurements including satisfaction with fit and comfort and with the quality and clarity of the sound. Follow-up in these studies varied widely, ranging from a few weeks or months to more than 20 years.

Most of the early studies from Canada and the United States describing the use of the BAHA were small, retrospective trials where investigators reported positive audiologic outcomes, few complications and high levels of user satisfaction in those who could not tolerate or were not suitable candidates for conventional air conduction hearing aids (Lustig, 2001; Niparko, 2003; Wazen, 1998). Several authors have reported improved hearing outcomes and functioning with the use of the BAHA. The BAHA is also associated with improvements in language development in children five years of age and older. In a retrospective, treatment outcome study, Lloyd and colleagues (2007) reported that children (n=85 ears, mean age at primary implantation 8.7 years) had "significant additional benefits in terms of speech recognition, sound quality, ease of use, and overall quality of life," despite experiencing adverse outcomes (e.g. trauma and failure of osseointegration were the most common reasons for failure) when implanted with the BAHA.

Indications for Bilateral BAHA for Conductive Hearing Loss

The implantation of bilateral BAHA has been evaluated in several small studies. Dutt and colleagues (2002) reported user satisfaction and speech intelligibility in 15 individuals with unilateral BAHA subsequently fitted with a bilateral BAHA. The benefits of bilateral amplification were compared to unilateral amplification in 11 of these individuals who used their second BAHA for 12 months or longer. Following a subjective analysis in the form of comprehensive questionnaires, objective testing was undertaken to assess specific issues such as 'speech recognition in quiet,' 'speech recognition in noise' and a modified 'speech-in-simulated-party-noise' (Plomp) test. 'Speech in quiet' testing revealed a 100% score with both unilateral and bilateral BAHA. With 'speech in noise,' all 11 individuals were reported as scoring "marginally better" with bilateral aids compared to best unilateral responses. A prospective study of 12 individuals reported by Priwin and colleagues (2004) demonstrated a significant improvement in sound localization with bilateral BAHA fitting. Furthermore, the authors reported an improvement in speech reception threshold in both quiet and in noise, concluding that the outcomes with bilateral BAHA were better than with unilaterally fitted BAHA. Bosman and colleagues (2001) evaluated bilateral fittings of the BAHA in 25 individuals with at least three months experience with using two BAHA. The authors reported a significant improvement in directional hearing and speech reception threshold for sentences in quiet (p<0.01) for the bilateral fittings compared to the unilateral fittings. Speech recognition in noise was also reported as significantly improved with a second BAHA.

Priwin and colleagues (2007) investigated whether fitting of bilateral BAHA in children with conductive bilateral hearing loss (BHL) provided additional hearing benefits. In this prospective case series, 22 children (15 controls) were studied with either conductive unaided or with unilateral hearing aid (UHL) or conductive BHL (with unilateral or bilateral BAHA). Baseline audiometry, tone thresholds in a sound field, speech recognition in noise and sound localization were tested with and without unilateral and bilateral hearing aids. The authors reported an additional BAHA in the children with BHL resulted in a tendency to have improved hearing in terms of better sound localization and speech recognition in noise.

The BAHA has been reported as successfully used in children younger than five years of age in Europe and the United Kingdom. However, the most recent update of the FDA notification (1999) lists age less than five years as a contraindication to use of the BAHA. A number of reports describe experience with preschool children or children with developmental issues that might interfere with maintenance of the implant and skin integrity. A two-stage procedure is used in young children with the fixture placed into the bone at the first stage and, after three to six months to allow for osseointegration, a second procedure to connect the abutment through the skin to the fixture. Davids and colleagues (2007) provided the BAHA to children less than five years of age for auditory and speech-language development, retrospectively comparing surgical outcomes for a group of children five years or younger (n=20) and a control group of older children (n=20). Children with cortical bone thickness greater than four millimeters underwent a single-stage procedure. The interstage interval for children having two-stage procedures was significantly longer in the study group to allow implantation in younger children without increasing surgical or postoperative morbidity. Two traumatic fractures occurred in the study group versus four in the older children. Three younger children required skin site revision. All children were wearing their BAHA at the time of writing. McDermott and colleagues (2008) reported on the role of the BAHA in 15 children (ages two to 15 years) with Down syndrome in a retrospective case analysis and postal survey of complication rates and quality of life outcomes. All of the children were using their BAHA after follow-up of 14 months. No fixtures were lost; skin problems were encountered in three children. All 15 children were reported as having improved social and physical functioning as a result of improved hearing.

BAHA for Unilateral Sensorineural Hearing Loss

Baguley and colleagues (2006) reviewed the evidence for use of a contralateral BAHA in adults with acquired unilateral sensorineural hearing loss. None of the four controlled trials in this meta-analysis reported a significant improvement in auditory localization with the BAHA (Bosman, 2003; Hol, 2004; Niparko, 2003; Wazen, 2003). However, speech discrimination in noise and subjective measures improved with these aids; for these parameters, use of the BAHA resulted in greater improvement than that obtained with the contralateral routing of signal (CROS) systems. The authors noted a number of shortfalls in these studies including bias in terms of participant selection (two studies), all four studies were underpowered, and double reporting of study participant outcomes. Lin and colleagues (2006) reported on use of the BAHA in 23 individuals with unilateral deafness, and noted that speech recognition in noise was significantly better with the BAHA than with the air-conduction CROS. While the report also comments that benefit was seen in those with moderate sensorineural hearing loss in the contralateral ear (25–50 dB), this conclusion was based on only five participants. Larger studies are needed before the BAHA can be considered for use in individuals with bilateral sensorineural hearing loss.

Indications for the BAHA Headband/Softband

The Headband or Softband for BAHA (FDA, 2000) is a non-surgical application of the hearing aid part of the BAHA intended for use in individuals who meet criteria for moderate to severe mixed bone conductive hearing loss or SSD. The BAHA with Softband has been suggested as a temporary solution for use in younger children until the strength and thickness of the bone of the skull behind the ear allows for surgical implantation of the titanium abutment. For bilateral conductive hearing losses, the BAHA with Softband  has been suggested to provide an average of 40.5 dB functional gain across the speech spectrum.

A number of small retrospective case series, comparative studies, and review publications suggest that infants and children under five years of age with bilateral congenital aural atresia (CAA) may benefit from an externally worn BAHA, prior to BAHA implantation (Dun, 2010; Priwin, 2007; Zarowski, 2011). Hol and colleagues (2005) evaluated the validity of a BAHA with Softband (fitted unilaterally and bilaterally) in two young children with severe bilateral conductive hearing loss due to CAA. In a small multicenter comparative study, 12 children (including the two children in the Hol, 2005 article) with bilateral CAA with a pure conductive hearing loss of around 60 dB HL were fitted with the BAHA with Softband (Verhagen, 2008). These children were retrospectively compared to a reference group of eight children selected from a database of those who had a conventional bone conduction hearing aid for bilateral CAA. The authors reported the mean aided hearing threshold of the children with the BAHA with Softband compared to the reference group was 27 dB HL, plus or minus 6 dB HL to 25 dB HL plus or minus 6 dB HL, respectively. Further results compared psychological and language development in five of the 12 children available from the BAHA with Softband group.

Ramakrishnan and colleagues (2011) used the Glasgow Benefit Inventory (GBI) and Listening Situation Questionnaire to report quality of life findings in a retrospective cross-sectional survey administered to parents of 22 children (n=109 total participants), some with skull and congenital/chromosomal abnormalities from inherited syndromes that involve unilateral (e.g. hemifocal microsomia) or bilateral hearing impairment (e.g. Treacher-Collins Syndrome, n=4/22) due to microtia or aural atresia. The youngest child utilizing an externally worn BAHA with Softband was six months of age. Overall, parents reported short-term satisfaction in the mean GBI scores for the children after three months of implanted BAHA or externally worn BAHA with Softband use. Despite the heterogeneous etiology of children in the study population, the authors suggest that "The utility of BAHAs for children with syndromes and craniofacial anomalies is poorly recognized, resulting in delays in aid fitting and therefore in early hearing rehabilitation." "In such cases, surgical reconstruction of the ear canal and middle-ear defects is not only technically challenging but also plagued by poor results (with a high rate of ear canal restenosis and limited functional hearing benefit). Hence, alternative treatment options such as Softband and BAHA may be of considerable benefit."

Christensen and colleagues (2010) conducted a retrospective five-year case review of ten children, six months to 16 years of age, with bilateral conductive hearing loss due to CAA and/or microtia who were initially fit with traditional bone-conduction hearing aids, progressed to the externally worn BAHA with Softband, and finally to a unilateral implanted BAHA. The amount of functional gain at 500, 1000, 2000, and 4000 Hz delivered by the various devices was examined as well as the threshold measures with each device at each frequency. The participants showed a statistically significant improvement when using the externally worn BAHA with Softband over traditional bone-conduction hearing aids.

Nicholson and colleagues (2011) retrospectively reviewed cases of 25 children, ages 6 months to 18 years with craniofacial disorders and bilateral conductive hearing loss, who were consistent full-time, externally worn, unilateral BAHA with Softband users as a prerequisite to surgical implantation. The primary study outcome used aided and unaided soundfield audiometric thresholds to measure functional gain. Audibility of the speech spectrum was verified by comparison with target aided thresholds. An analysis of the results revealed an improvement in soundfield thresholds using the BAHA with Softband for the four octave frequencies; percentages of thresholds meeting target levels were significant at all frequencies, exceeding the 80% criterion. The investigators concluded use of the BAHA with Softband provided audibility of the speech spectrum for infants and children with bilateral congenital conductive hearing loss.

In summary, while there are not published, randomized controlled trials comparing the efficacy of an externally worn BAHA with Softband (i.e. bone conduction hearing aid) to an implantable BAHA in measurements of directional hearing, sound localization, and speech recognition in noise, this device may be appropriate for individuals under age five who are not yet appropriate for a surgically implanted device, in particular infants and children with bilateral CAA who cannot be fitted for standard acoustic hearing aids placed in the ear canal. 

Hearing loss can be classified as conductive, sensorineural, or mixed hearing loss. Conductive hearing loss involves the external and middle ear and is due to mechanical or physical blockage of sound as a result of excessive cerumen, a punctured eardrum, birth/congenital defects such as congenital aural atresia (CAA), ear infections or heredity. In sensorineural or "nerve" hearing loss, the auditory cranial nerve or part of the bone of the inner ear is damaged due to birth-related condition, long-term viral or bacterial infections, trauma, exposure to loud noises, the use of certain drugs, fluid buildup in the middle ear, or a benign tumor in the inner ear (acoustic neuroma). Mixed hearing loss is conductive hearing loss coupled with sensorineural hearing loss. Normal range or no impairment of hearing occurs at 0 to 20 dB threshold. The American Speech-Language-Hearing Association (ASLHA, 2010) defines the degree (severity) of hearing loss (HL) as mild (20 to 40 dB), moderate (40 to 60 dB), severe (60 to 80 dB), and profound (greater than or equal to 80 dB).

Conventional external hearing aids can be generally categorized as air conduction hearing aids or bone conduction hearing aids. Air conduction hearing aids are designed for placement in several locations including fitted behind the ear or on the body (both require the use of an ear mold), in the outer ear, ear canal or almost entirely in the canal, or as a contralateral routing of signal (CROS) hearing aid (i.e. a microphone is located on the impaired hearing side and transmits a signal wirelessly over a radio frequency to the normal hearing ear via an ear mold). Use of ear molds may be problematic in individuals with chronic middle ear and ear canal infections, atresia of the external canal, or an ear canal that cannot accommodate an ear mold. In these individuals, bone conduction hearing aids may be an alternative. External bone conduction hearing aids function by transmitting sound waves through the bone to the ossicles of the middle ear. The external aids 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 eyeglasses. These hearing aids may be associated with either pressure headaches or soreness.

The BAHA system utilizes an FDA-approved, bone-anchored, bone conduction hearing aid, specifically indicated for individuals five years of age and older. The indications for the BAHA have expanded since the initial approval. The BAHA is currently used for individuals with unilateral or bilateral conductive or mixed (conductive and sensorineural) hearing loss, and for unilateral sensorineural hearing loss. The BAHA processor is coupled to a titanium fixture (screw) protruding through the skin located in the upper mastoid region on the temporal bone where it has fused with the bone in a process called "osseointegration." The BAHA system bypasses the middle ear altogether, sending sound around the area, naturally stimulating the cochlea through bone conduction. The difference between the standard bone conduction hearing aid and the bone-anchored hearing aid is direct stimulation of the bone instead of stimulation through the skin. The BAHA Divino, BAHA Intenso, BAHA Cordelle II, and BAHA BP100 (a substantially equivalent processor to predicate models) are the available FDA-approved sound processor models. The BAHA Divino and BP100 may be utilized by individuals with a pure tone average bone conduction threshold of 45 dB or better (FDA, 2004; FDA, 2009), the BAHA Intenso for individuals with pure tone average bone conduction threshold of 55 dB or better (FDA, 2008), while the Cordelle II is indicated for more severe hearing loss, with a pure tone average bone threshold of 65 dB or better (FDA, 2008).

Implantable or bone-anchored conduction hearing aids are recommended for individuals who are unable to use conventional air conduction hearing aids or have undergone ossicular replacement surgery because of chronic otitis media, congenital malformation of the middle/external ear or other acquired malfunctions of the middle or external ear canals which preclude wearing of a conventional air conduction hearing aid. Consideration should be given to the individual's psychological, physical, emotional and developmental capabilities of maintaining hygiene as the skin is adjacent to the implant abutment. For children and individuals with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation.

The Headband/Softband for BAHA received FDA 510(k) clearance in October 2000 as substantially equivalent to devices already on the market. The Headband/Softband consists of an elastic band with a plastic disc-like snap connector sewn into the band. A BAHA sound process is attached to the plastic connector and adjusted to the size of the individual's head, secured with a Velcro^® fastener. The sound processor is held against the skin behind the ear, or at another bony location of the skull, through pressure from the band. In this application there is no implantation surgery of an abutment into the skull. The Headband/Softband functions in the same manner as a conventional bone conduction hearing aid, with the amplified vibrational sounds transmitted transcutaneously to the bones of the skull for transmission to the cochlea. The signal is weakened as it passes through the skin (attenuation). The manufacturer of the BAHA system cautions against use of the Softband during the titanium implant/fixture healing process. The sound processor must not be placed on top of the abutment/implant as it may jeopardize osseointegration. In addition, the Softband contains natural rubber latex that may cause an allergic reaction in some individuals.

Conductive hearing loss: Hearing loss that occurs when sound is conducted inefficiently through the outer ear canal to the eardrum and the small bones (ossicles) of the middle ear; involves a reduction in sound level or the ability to hear faint sounds.

Congenital aural atresia (CAA): A rare spectrum of congenital deformities present at birth that involve some degree of failure of the development of the external auditory canal; commonly accompanied by abnormalities of both the middle ear bones in various degrees, as well as the external ear, including microtia (i.e. small ear) or incomplete development of the auricle (the outer projecting portion of the ear).

Decibel (dB): A unit for expressing the loudness of sound.

Hearing loss (HL): Any degree of impairment of the ability to apprehend sound.

Hertz (Hz): A unit of frequency equivalent to 1 cycle per second.

Mixed hearing loss:  Hearing loss that is both conductive and sensorineural, occurring in one or both ears.

Otitis: Inflammation or infection of the ear.

Pure tone average (PTA): The average of hearing sensitivity at 0.5, 1, 2, and 3 kHz.

Sensorineural hearing loss: A permanent hearing loss related to the sensory or neural structures responsible for hearing that involves a reduction in sound level or ability to hear faint sounds; affects speech understanding or the ability to hear clearly; the involved structures include, but are not limited to, the cochlea and the acoustic nerve.

Single sided deafness (SSD™): Significant or total hearing loss in one ear; also known as unilateral sensorineural hearing loss. SSD may be a result of surgery to treat acoustic neuroma or other tumors of the eighth cranial nerve.

Temporal bone: A bone located on the side of the head that is part of the skull.

Transcutaneous: Refers to a device or medication applied directly to unbroken skin.

Tympanic membrane: The membrane in the ear that vibrates to sound; referred to as the eardrum.

The following codes for treatments and procedures applicable to this document 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 when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Baguley DM, Bird J, Humphriss RL, Prevost AT. The evidence base for the application of contralateral bone anchored hearing aids in acquired unilateral sensorineural hearing loss in adults. Clin Otolaryngol. 2006; 31(1):6-14.
2. Bosman AJ, Hol MK, Snik AF, et al. Bone-anchored hearing aids in unilateral inner ear deafness. Acta Otolaryngol. 2003; 123(2):258-260.
3. Christensen L, Smith-Olinde L, Kimberlain J, et al. Comparison of traditional bone-conduction hearing AIDS with the Baha system. J Am Acad Audiol. 2010; 21(4):267-273.
4. Davids T, Gordon KA, Clutton D, et al. Bone-anchored hearing aids in infants and children younger than 5 years. Arch Otolaryngol Head Neck Surg. 2007; 133(1):51-55.
5. Dun CA, de Wolf MJ, Mylanus EA, et al. Bilateral bone-anchored hearing aid application in children: the Nijmegen experience from 1996 to 2008. Otol Neurotol. 2010; 31(4):615-623.
6. Dutt SN, McDermott AL, Burrell SP, et al. Patient satisfaction with bilateral bone-anchored hearing aids: the Birmingham experience. J Laryngol Otol Suppl. 2002; (28):37-46.
7. Dutt SN, McDermott AL, Burrell SP, et al. Speech intelligibility with bilateral bone-anchored hearing aids: the Birmingham experience. J Laryngol Otol Suppl. 2002; (28):47-51.
8. Dutt SN, McDermott AL, Jelbert A, et al. Day to day use and service-related issues with the bone-anchored hearing aid: the Entific Medical Systems questionnaire. J Laryngol Otol Suppl. 2002; (28):20-28.
9. Dutt SN, McDermott AL, Jelbert A, et al. The Glasgow benefit inventory in the evaluation of patient satisfaction with the bone-anchored hearing aid: quality of life issues. J Laryngol Otol Suppl. 2002; (28):7-14.
10. Granstrom G, Bergstrom K, Odersjo M, Tjellstrom A. Osseointegrated implants in children: experience from our first 100 patients. Otolaryngol Head Neck Surg. 2001; 125(1):85-92.
11. Granstrom G, Tjellstrom A. The bone-anchored hearing aid (BAHA) in children with auricular malformations. Ear Nose Throat J. 1997; 76(4):238-247.
12. Hakansson BE, Carlsson PU, Tjellstrom A, Liden G. The bone-anchored hearing aid: principal design and audiometric results. Ear Nose Throat J. 1994; 73(9):670-675.
13. Hakansson BE, Liden G, Tjellstrom A, et al. Ten years of experience with the Swedish bone-anchored hearing system. Ann Otol Rhinol Laryngol Suppl. 1990; 151:1-16.
14. Hol MK, Bosman AJ, Snik AF, et al. Bone-anchored hearing aid in unilateral inner ear deafness: a study of 20 patients. Audiol Neurootol. 2004; 9(5):274-281.
15. Hol MK, Cremers CW, Coppens-Schellekens W, Snik AF. The BAHA Softband. A new treatment for young children with bilateral congenital aural atresia. Int J Pediatr Otorhinolaryngol. 2005; 69(7):973-980.
16. Lin L, Bowditch S, Anderson M, et al. Amplification in the rehabilitation of unilateral deafness: Speech in noise and directional hearing effects with bone-anchored hearing and contralateral routing of signal amplification. Otol Neurotol. 2006; 27(2):172-182.
17. Lloyd S, Almeyda J, Sirimanna KS, et al. Updated surgical experience with bone-anchored hearing aids in children. J Laryngol Otol. 2007: 121(9):826-831.
18. Lustig LR, Arts HA, Brackmann DE, et al. Hearing rehabilitation using the BAHA bone-anchored hearing aid: results in 40 patients. Otol Neurotol. 2001; 22(3):328-334.
19. McDermott AL, Dutt SN, Reid AP, Proops DW. An intra-individual comparison of the previous conventional hearing aid with the bone-anchored hearing aid: the Nijmegen group questionnaire. J Laryngol Otol Suppl. 2002; (28):15-19.
20. McDermott AL, Dutt SN, Tziambazis E, et al. Disability, handicap and benefit analysis with the bone-anchored hearing aid: the Glasgow hearing aid benefit and difference profiles. J Laryngol Otol Suppl. 2002; (28):29-36.
21. McDermott AL, Williams J, Kuo MJ. The role of bone anchored hearing aids in children with Down syndrome. Int J Pediatr Otorhinolaryngol. 2008; 72(6):751-757.
22. McLarnon CM, Davison T, Johnson IJ. Bone-anchored hearing aid: comparison of benefit by patient subgroups. Laryngoscope. 2004; 114(5):942-944.
23. Nicholson N, Christensen L, Dornhoffer J, et al. Verification of speech spectrum audibility for pediatric baha softband users with craniofacial anomalies. Cleft Palate Craniofac J. 2011; 48(1):56-65.
24. Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003; 24(1):73-78.
25. Priwin C, Jönsson R, Hultcrantz M, Granström G. BAHA in children and adolescents with unilateral or bilateral conductive hearing loss: a study of outcome. Int J Pediatr Otorhinolaryngol. 2007; 71(1):135-145.
26. Priwin C, Stenfelt S, Granström G, et al. Bilateral bone-anchored hearing aids (BAHAs): an audiometric evaluation. Laryngoscope. 2004; 114(1):77-84.
27. Ramakrishnan Y, Marley S, Leese D, et al. Bone-anchored hearing aids in children and young adults: the Freeman Hospital experience. J Laryngol Otol. 2011; 125(2):153-157.
28. Snik AF, Mylanus EA, Cremers CW. The bone-anchored hearing aid compared with conventional hearing aids. Audiologic results and the patients' opinions. Otolaryngol Clin North Am. 1995; 28(1):73-83.
29. Snik AF, Mylanus EA, Cremers CW. The bone-anchored hearing aid: a solution for previously unresolved otologic problems. Otolaryngol Clin North Am. 2001; 34(2):365-372.
30. Stenfelt S, Hakansson B, Jonsson R, Granstrom G. A bone-anchored hearing aid for patients with pure sensorineural hearing impairment: a pilot study. Scand Audiol. 2000; 29(3):175-185.
31. van der Pouw CT, Carlsson P, Cremers CW, Snik AF. A new more powerful bone-anchored hearing aid: first results. Scand Audiol. 1998; 27(3):179-182.
32. van der Pouw CT, Mylanus EA, Cremers CW. Percutaneous implants in the temporal bone for securing a bone conductor: surgical methods and results. Ann Otol Rhinol Laryngol. 1999; 108(6):532-536.
33. van der Pouw CT, Snik AF, Cremers CW.  The BAHA HC 200/300 in comparison with conventional bone conduction hearing aids. Clin Otolaryngol Allied Sci. 1999; 24(3):171-176.
34. Verhagen CV, Hol MK, Coppens-Schellekens W, et al. The Baha Softband. A new treatment for young children with bilateral congenital aural atresia. Int J Pediatr Otorhinolaryngol. 2008; 72(10):1455-1459.
35. Wazen JJ, Caruso M, Tjellstrom A. Long-term results with the titanium bone-anchored hearing aid: the U.S. experience. Am J Otol. 1998; 19(6):737-741.
36. Wazen JJ, Spitzer JB, Ghossaini SN, et al. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg. 2003; 129(3):248-254.
37. Zarowski AJ, Verstraeten N, Somers T, et al. Headbands, testbands and softbands in preoperative testing and application of bone-anchored devices in adults and children. Adv Otorhinolaryngol. 2011; 71:124-131.

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Rockville, MD: FDA. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed on June 13, 2011:
   • BAHA^® BP100. No. K090720.  June 17, 2009.
   • BAHA^® Cordelle II. No. K080363. April 10, 2008.
   • BAHA™ for Single Sided Deafness. No. K021837. August 30, 2002.
   • BAHA^® Intenso™. No. K081606. August 28, 2008.
   • Bilateral Fitting of BAHA™. No. K011438. July 23, 2001.
   • Branemark Bone-Anchored Hearing Aid (BAHA™) System. No. K984162. June 28, 1999.
   • Headband for BAHA™. No. K002913. October 17, 2000.

1. American Speech-Language-Hearing Association (ASLHA). Types of hearing loss. Available at: http://www.asha.org/public/hearing/disorders/types.htm. Accessed on June 13, 2011.
2. National Institute on Deafness and Other Communication Disorders (NIDCD). Hearing aids. Available at: http://www.nidcd.nih.gov/staticresources/health/hearing/HearingAids07.pdf. Accessed on June 13, 2011.
3. National Institute on Deafness and Other Communication Disorders (NIDCD). Vestibular schwannoma (acoustic neuroma) and neurofibromatosis. Available at: http://www.nidcd.nih.gov/health/hearing/acoustic_neuroma.asp. Accessed on June 13, 2011.

BAHA
BAHA BP100
BAHA Cordelle II
BAHA Divino
BAHA Intenso
Bone-Anchored Hearing Aid
Bone Conduction Hearing Aid

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.