A bone-anchored implant system combines 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 osseointegration through which living tissue integrates with titanium in the implant over a period of 3 to 6 months, conducting amplified and processed sound 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. They may also be used with CROS as an alternative to an AC hearing aid with CROS for individuals with unilateral sensorineural hearing loss.

 

 

 

 

 

 

 

 

 

 

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 the FDA through the 510(k) process for indications similar to the BAHA. However, the manufacturer, Sonitus Medical, closed in 2015.Because this system has no implanted components, it is not addressed in the current policy.

 

  

 

 

 

 

L8693: Auditory osseointegrated device abutment, any length, replacement only.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

An implantable bone conduction hearing aid meets member certificate of benefit Primary Coverage Criteria as an alternative to an air conduction hearing aid in the following patients with single-sided deafness and normal hearing in the other ear for members with:

 

Other uses of bone-conduction (bone-anchored) hearing aids, including, but not limited to,  use in patients with bilateral sensorineural hearing loss does not meet primary coverage criteria and are not covered.

 

Other uses of bone-conduction (bone-anchored) hearing aids, including. but not limited to, use in patients with bilateral sensorineural hearing loss is considered investigational and not covered for contracts without primary coverage criteria language.  Investigational services are a contract exclusion.

 

 

 

 

 

The policy was updated based on a literature search using MEDLINE.  None of the information identified leads to a change to the policy statements. Two studies of bone-anchored hearing aids for congenital unilateral conductive hearing impairment are reported by Kunst et al. In 1 study aided and unaided hearing was assessed in 20 patients using sound localization and speech recognition-in-noise tests (Kunst, 2008).  Many patients showed unexpectedly good unaided performance, however non-significant improvements were observed in favor of the BAHA. Six of 18 patients with a complete data set showed no improvement at all; however, compliance with BAHA use in this patient group was remarkably high, suggesting patient benefit. The same authors evaluated 10 adults and 10 children using 2 disability-specific questionnaires and found an overall preference for the BAHA over unaided hearing in several specific hearing situations (Kunst, 2008).  Improvement on the Glasgow children’s benefit inventory was most prominent in the learning domain. The 10 adults showed an already good score on the Speech, Spatial and Qualities of hearing scale in the unaided situation. Tringali et al surveyed patients using a BAHA to compare patient satisfaction by indication: 52 respondents with conductive or mixed hearing loss (44 with chronic otitis and 8 with malformation of the middle ear) compared with 118 with single-sided deafness (2 after surgery for meningioma, idiopathic sudden deafness, sensorineural hearing loss complicating surgery of the middle ear) (Tringali, 2008).  Levels of satisfaction and quality of life were significantly poorer in the SSD than in the CHL group, although generally good with the exception of sound localization.

 

The BAHA device has been used successfully in children younger than 5 years in Europe and the United Kingdom. (The most recent [1999] update of the FDA notification lists age less than 5 years as a contraindication.) A number of reports describe experience with preschool children or children with developmental issues that might interfere with maintenance of the device 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 3 to 6 months to allow for osseointegration, a second procedure to connect the abutment through the skin to the fixture. Davids and colleagues at the University of Toronto provided BAHA devices to children less than 5 years of age for auditory and speech-language development and retrospectively compared surgical outcomes for a study group of 20 children 5 years or younger and a control group of 20 older children (Davids, 2007).  Children with cortical bone thickness greater than 4 mm underwent a single-stage procedure. The interstage interval for children having 2-stage procedures was significantly longer in the study group to allow implantation in younger patients without increasing surgical or postoperative morbidity. Two traumatic fractures occurred in the study group versus 4 in the older children. Three younger children required skin site revision. All children were wearing their BAHA devices at time of writing. McDermott reported on the role of bone-anchored hearing aides in children with Down syndrome in a retrospective case analysis and postal survey of complication rates and quality of life outcomes for 15 children aged 2 to 15 years (McDermott, 2008).   All patients are using their BAHA devices after follow-up of 14 months. No fixtures were lost, and skin problems were encountered in 3 patients. All 15 patients had improved social and physical functioning as a result of better hearing.

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

 

 

    

 

 

 

Since the publication of the Health Technology Assessment Program systematic review, a number of observational studies have evaluated specific aspects of BAHA implantation or reported outcomes in specific populations. Several observational studies have suggested that newer-generation BAHAs with fully digital signal processors improve hearing to a greater degree than earlier-generation devices (Kompis, 2014; Hill-Feltham, 2014).

 

In 2014, Farnoush et al retrospectively compared BAHA placement with reconstruction of the external auditory canal for children and adolescents with congenital aural atresia or stenosis who were treated at a single institution from 1988 to 2011 (Farnoush, 2014). Sixty-eight patients were included, 49 who underwent external auditory canal reconstruction (EACR) and 19 who received a BAHA. Groups differed significantly in terms of age, presence of bilateral atresia, and presence of an associated syndrome. Audiologic data were available for 41 patients. At short-term (<6 months post-surgery) follow-up, the BAHA group had larger hearing gains on AC than the EACR group (44.3 dB vs 20.0 dB; p<0.001); similarly, the BAHA group had larger hearing gains at long term (>1 year post-surgery) follow-up (44.5 dB vs 15.3 dB; p<0.001). Quality-of-life scores and requirements for revision surgery did not differ significantly between the groups.

 

 

 

Several centers have reported on findings from observational studies designed to evaluate the benefits of BAHA for patients with unilateral sensorineural hearing loss, or SSD. Most of these studies have been retrospective. In 2014, Peters et al reported results from a systematic review of the use of BAHA devices with contralateral routing of sound systems for SSD (Peters, 2014). The authors included 6 studies that met eligibility criteria, 5 of which were considered to have moderate to high directness of evidence and low to moderate risk of bias. The 5 studies evaluated included a total of 91 patients and were noted to have significant heterogeneity in the populations included. For speech perception in noise, there was not consistent improvement with aided hearing over unaided hearing in all environments. All studies reported equal sound localization in the aided and unaided conditions, and quality-of-life measures were similar for the aided and unaided conditions.

 

Lin et al (2006) reported on use of BAHAs in 23 patients with unilateral deafness and noted that speech recognition in noise was significantly better with the BAHA device than with the AC CROS device (Lin, 2006). While the report also commented that benefit was seen in those with moderate sensorineural hearing loss in the contralateral ear (25-50 dB), this conclusion was based on 5 patients. Larger studies are needed to support the use of BAHA for bilateral sensorineural hearing loss.

 

 

 

In 2013, Kiringoda et al reported on a meta-analysis of complications related to BAHA implants. Included in the meta-analysis were 20 studies that evaluated complication in 2134 adult and pediatric patients who received a total of 2310 BAHA implants (Kiringoda, 2013). While the quality of available studies was considered poor and lacking in uniformity, complications related to BAHA implants were mostly minor skin reactions. The incidence of Holgers grade 2 to 4 skin reactions was 2.4% to 38.1% in all studies (grade 2, red and moist tissue; grade 3, granulation tissue; and grade 4, infection leading to removal of the abutment). The incidence of failed osseointegration was 0% to 18% in adult and mixed population studies and 0% to 14.3% in pediatric population studies. The incidence of revision surgery was 1.7% to 34.5% in adult and mixed population studies and 0.0% to 44.4% in pediatric population studies. Implant loss occurred in 1.6% to 17.4% in adult and mixed population studies and in 0.0% to 25% in pediatric studies.

 

In 2014, Allis et al conducted a prospective observational cohort study with a retrospective historical control to evaluate complication rates of skin overgrowth, infection, and the need for revision surgery associated with a BAHA implant with a longer (8.5 mm) abutment (Allis, 2014). Twenty-one subjects were treated with the 8.5 mm abutment implant from 2011 to 2012 and were compared with 23 subjects treated with a 5.5 mm-abutment implant from 2010 to 2011. Groups were generally similar at baseline, with the exception that the 8.5 mm abutment implant patients were older (62 years vs 48 years, p=0.012). Patients in the longer abutment group were less likely to experience infection (10% vs 43%; p=0.02), skin overgrowth (5% vs 41%; p=0.007), and need for revision (10% vs 45%; p=0.012).

 

Also in 2014, Calvo Bodnia et al reported results from a retrospective cohort study of patients implanted with a BAHA implant at a single center from 2004 to 2012, with a focus on implant loss, adverse skin reactions, skin overgrowth, and discomfort leading to device removal (Calvo, 2014). The authors reviewed 185 implantations in 176 patients. Ten patients were younger than 16 years (11 implantations), 117 were between 17 to 64 years (121 implantations), and 49 patients were between 65 and 86 years (53 implantations). Adverse skin reactions occurred in 14% of patients, and spontaneous implant loss occurred in 3.8%, at a mean of 2.5 years. The abutment was removed because of discomfort and/or no benefit in 10% overall.

 

In another retrospective cohort study, Rebol reported skin/soft tissue reactions for 47 patients implanted with BAHA devices (Rebol, 2014). Over 9 years of follow-up, the percentage of patients with skin inflammation of 2 or greater on Holger’s skin inflammation grading system ranged from 6% to 22%. Three patients with grade 4 inflammation required fitting of a longer abutment due to skin thickening.

 

In a large retrospective cohort study of 763 BAHA implants in 571 patients treated at a single institution from 1977 to 2011, Larsson et al (2014) reported on rates of implant loss and removal (Larrson, 2014). A total of 141 implants (18%) were lost over a mean follow-up of 6.6 years, 109 (14%) due to loss of osseointegration and 21 (3%) due to trauma, with 11 elective removals.

 

Different techniques for surgically implanting BAHA devices and specific BAHA designs are under investigation to yield improved safety outcomes. Fontaine et al (2014) compared complication rates after 2 different surgical techniques for BAHA implantation among 32 patients treated from 2004 to 2011 (Fontaine, 2014). Complications requiring surgical revision occurred in 20% of cases who underwent a skin flap implantation method (N=20) and in 38% of cases who underwent a full-thickness skin graft implantation method (N=21; P=0.31). Hultcrantz et al (2014) reported shorter surgical times and fewer cases of numbness and peri-implant infections in 12 patients treated with a non-skin-thinning technique, compared with 24 patients treated with either a flap or dermatome implantation technique (Hultcrantz, 2014). In a comparison of 2 types of BAHA devices, one with a 4.5 mm diameter implant with a rounded 6 mm abutment (N=25) and one with a 3.75 mm diameter implant with a conically-shaped 5.5 mm abutment (N=52), Nelissen et al (2014) reported that implant survival was high for both groups over 3 years of follow-up, although the conically-shaped abutment had greater stability (Nelissen, 2014). Singam et al (2014) reported results of a BAHA implantation technique without soft tissue reduction in conjunction with a longer device abutment in 30 patients (Singam, 2014). While 25 patients had no post-operative complications, 3 developed pain requiring soft tissue reduction.

 

 

O’Niel et al (2014) reported outcomes for 10 pediatric patients with conductive hearing loss treated with the Otomag Sophono device at a single center (O’Niel, 2014). A total of 14 ears were implanted with no surgical complications. The skin complication rate was 35.7%, including skin breakdown (n=2) and pain and erythema (n=5); negative outcomes resulted in 5 (36%) of 14 ears having significant enough difficulties to discontinue use for a period. The mean aided pure-tone average (PTA) was 20.2 dB hearing level, with a mean functional gain of 39.9 dB hearing level. Patients without skin complications consistently used their devices, with an average daily use of 8 to 10 hours.

 

Centric et al (2014) also reported outcomes for 5 pediatric patients treated with the Otomag Sophono device at a single center (Centric, 2014). Etiologies of hearing loss were heterogeneous and included bilateral moderate or severe conductive hearing loss and unilateral sensorineural hearing loss. The average improvement in PTA was 32 dB hearing level, and the average improvement in speech response threshold was 28 dB hearing level. All patients were responding in the normal to mild hearing loss range in the operated ear after device activation.

 

In a similar study, Marsella et al (2014) reported outcomes for 6 pediatric patients treated with the Otomag Sophono device at a single center (Marcella, 2014).  All subjects had bilateral conductive or mixed hearing loss, and 3 had associated syndromes. Patients ranged in age from 5 to 17 years. Post-operatively, 1patient experienced ulceration of the skin under the magnet, which was successfully treated, and 1patient experienced pain associated with the device leading to discontinuation of device use. The median improvement in PTA was 33 dB hearing level and the median free-field pure tone average (0.5-3 kHz) with the device was 32.5 dB hearing level.

 

 

 

 

 

 

 

 

 

 

 

 

 

A limited amount of data is available comparing transcutaneous to percutaneous bone-anchored conduction devices. In 2013, Hol and colleagues compared percutaneous BAHA implants to partially implantable magnetic transcutaneous bone-conduction hearing implants using the Otomag Sophono device in 12 pediatric patients (age range, 5-12 years), who had congenital unilateral CHL (Hol, 2013). Sound-field thresholds, speech recognition threshold, and speech comprehension at 65 dB were somewhat better in patients with the BAHA implant (n=6) than those with the partially implantable hearing device (n=6). Using a skull simulator, output was 10 to 15 dB less with the partially implantable device than with the BAHA device.

 

Iseri and colleagues described a retrospective, single-center study from Turkey comparing 21 patients treated with a transcutaneous, fully implantable BAHA to 16 patients treated with a percutaneous device (the Baha Attract) (Sieri, 2015). Groups were generally similar at baseline, with most individuals undergoing BAHA placement for chronic otitis media. Operating time was longer in patients treated with the transcutaneous partially implantable devices (46 minutes vs 26 minutes, p<0.05). Three patients treated with percutaneous devices had Holger grade 2 skin reactions and 2 had stopped using their devices for reasons unrelated to skin reactions. Mean thresholds for frequencies 0.5 to 4.0 kHz were 64.4 dB without the BAHA and 31.6 dB with the BAHA in the percutaneous device group, and 58.3 dB without the BAHA and 27.2 dB with the BAHA in the transcutaneous device group. Frequency-specific threshold hearing gains did not differ significantly between groups. Mean hearing gain measured by speech reception threshold was statistically significantly smaller in the percutaneous group (24 dB vs 36.7 dB, p=0.02).

 

Powell and colleagues reported outcomes from a retrospective study that included 6 patients treated with the Otomag Sophono device and 6 treated with the BAHA Attract device (Powell, 2015). Ten subjects were identified as the primary author’s patients and the remaining were identified through an Australian national hearing database. In the BAHA Attract group, mean AC thresholds across 4 frequencies (0.5, 1, 2, and 4 kHz) improved from 60.8 dB in the unaided state to 30.6 dB in the aided state. In the Sophono group, the mean 4-frequency AC thresholds improved from 57.8 dB in the unaided state to 29.8 dB in the aided state. Speech discrimination in noise scores did not differ significantly between devices.

 

Baker and colleagues reported pooled outcomes for the first 11 patients treated with the Otomag Sophono and the first 6 patients treated with the Baha Attract (Baker, 2015).  Pre- and postimplant audiometric data were available for 11 ears in the Sophono group and 5 in the Baha Attract group. Average improvement over all frequencies ranged from a 24- to 43-dB hearing level in the Sophono group and a 32- to 45-dB hearing level in the Baha Attract group. Average improvement in PTA was a 38-dB hearing level in the Sophono group and a 41-dB hearing level in the Baha Attract group.

 

Additional single-center observational series have described clinical experience with transcutaneous partially implantable BAHA devices. Marsella and colleagues reported outcomes for 6 pediatric patients treated with the Otomag Sophono device for CHL or mixed hearing loss (Marsella, 2014).  Median improvement in PTA was 33 dB HL and median free-field PTA (0.5-3 kHz) with the device was 32.5 dB HL.

 

Carr and colleagues reported outcomes for 10 patients treated with the Baha Attract device, most commonly for chronic suppurative otitis media (n=3) and SSD (n=3) (Carr, 2015). Patients did not show significant improvement in word discrimination score.

 

 

Snapp and colleagues reported a prospective single-center study of 27 patients with unilateral severe-profound sensorineural hearing loss who had either a CROS (n=13) or transcutaneous BAHA (n=14) device (Snapp, 2017). Mean device use was 66 months for the BAHAs and 34 months for CROS devices. Both BAHA and CROS groups had significant improvement in speech-in-noise performance, but neither showed improvement in localization ability. There were no differences between the devices for subjective measures of posttreatment residual disability or satisfaction as measured by the Glasgow Hearing Aid Benefit Profile (GHABP).

 

Verheijand colleagues published a systematic review on complications of tissue preservation surgical techniques with percutaneous BAHA devices including 18 studies with 381 devices (Verheijand, 2016). The implantation techniques reported in the studies were as follows: punch method, 4 studies (81 implants); linear incision technique without soft tissue reduction, 13 studies (288 implants); and Weber technique, 1 study (12 implants). Indications for surgery were SSD (n=68), sensorineural hearing loss (n=4), mixed hearing loss (n=65), or CHL (n=66). The Holgers classification was used to grade soft tissue reactions (grade 0, no reaction; grade 2, red and moist tissue; grade 3, granulation tissue; grade 4, removal of skin-penetrating implant necessary due to infection). The incidence of Holgers 3 was 2.5% with the punch technique, 5.9% with the linear incision technique, and 0% with the Weber technique. Holgers 4 was reported in 1 patient implanted with the linear incision technique.

 

Roplekar and colleagues compared skin-related complications of the traditional skin flap method to the linear incision method performed by a single surgeon in 117 patients with at least 1 year of follow-up (Roplekar, 2016). Twenty-one (24%) patients experienced skin-related complications in the skin flap group (12 skin overgrowths, 8 wound infections, 1 numbness) and 3 (10%) patients experienced complications in the linear incision group (3 wound infections).

 

 

Dimitriadis and colleagues reported a systematic review of observational studies of the BAHA Attract device including 10 studies (total N=89 patients; range, 1-27 patients) (Dimitriadis, 2016). Seventeen (19%) of the patients were children, of whom 5 had unilateral sensorineural hearing loss and 4 had CHL. Of the 27 (45%) adults, 22 had unilateral sensorineural hearing loss and 11 (18%) had bilateral mixed hearing loss. Audiologic and functional outcome measures and the timing of testing varied greatly in the studies. Summary measures were not reported. In general, audiologic and functional outcomes measured pre- and postimplantation showed improvement, although statistical comparisons were lacking in some studies.

 

Reddy-Kolanu and colleagues reported on complications of the BAHA Attract (n=34) from a case series included all patients implanted in a single center between October 2013 and April 2015 (Reddy-Kolanu, 2016). Patients ranged in age from 8 to 64 years, and follow-up ranged from 3 to 20 months. Twenty-three patients had no significant postoperative problems. Five patients required an alteration in magnet strength primarily due to implant site tenderness. One patient reported distressing tinnitus; 1 had the implant changed to an abutment system due to infection; and 1 had the magnet removed following trauma to the implant site. One patient has ongoing psoriasis problems. Two patients were converted to a newer, lighter sound processor.

 

 

 

A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.