A Systematic Review of Surgical Characteristics and Adverse Events of an Active,Transcutaneous Bone Conduction Device

Abstract

Objective:

A new, active transcutaneous bone conduction device (BCD) was FDA-approved in 2019 in the USA. This systematic review sought to evaluate early outcomes associated with Osia implantation.

Methods:

A systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Four databases were reviewed: PubMed, Scopus, Cochrane CENTRAL, and CINAHL. Studies were included if they described audiometric, surgical characteristics/complications, or adverse events associated with the Osia BCD. Exclusion criteria: non-English language studies, animal investigations, reviews/meta-analyses, case reports, database studies.

Results:

Eighteen studies with 336 patients were included. Mean age at implantation was 37.9 years. About 79.5% of patients had MHL/CHL and 19.5% had SSD/SHL. Mean operative time was 71.6 minutes. Mean PTA gain from unaided conditions was 35.4 dB. Mean functional gain at high frequency (6 kHz and above) from aided conditions was 16.1 dB. Mean improvement in speech recognition thresholds was 19.1 dB from unaided conditions. Adverse events (all types) were reported in 20.1% of cases. Across all studies, the postoperative infection rate was 5%. About 2% of patients reported magnet retention issues. About 1.65% of cases were complicated by hematomas.

Conclusions:

Under systematic literature review, the Osia BCD has been associated with low complication rates, relatively short operative times, and good audiometric and speech outcomes, notably high frequency gain >6 kHz. More advanced audiometric outcome reporting remains limited and audiometric data and patient reported outcome measures were reported heterogeneously.

Keywords

active transcutaneous hearing device bone conduction implant hearing loss conductive hearing loss Osia bone-anchored hearing aid

Introduction

Bone conduction devices (BCD), which have been used since 1977,¹ are utilized in the treatment of either conductive or mixed hearing loss, and in cases of single-sided deafness. BCDs are often considered in cases where traditional hearing aids may be contraindicated or difficult to use, including patients with cholesteatoma, chronic otitis media, perforation, and external canal atresia/stenosis.² BCDs can be worn as a peripheral device or can be surgically implanted, in which case they are often designated bone anchored hearing aids (BAHA). In either version of the technology, the transmission of sound to the inner ear is achieved by propagating acoustic vibrations through the osseous temporal bone.³

Two different categories of surgical BAHAs exist. Percutaneous BAHAs transmit vibrations from an externally worn processor-transducer through a connecting metallic abutment, which is anchored into the outer table of the calvarium and extends through the scalp skin and soft tissues. Although effective, percutaneous devices are more susceptible to problems with hygiene, soft tissue infections, and cosmetic perception.⁴ This is compared to transcutaneous BAHAs, for which the implanted portion is fully subcutaneous and maintains a magnetic, connection with an externally worn active processor/transducer. Transcutaneous devices have been shown to dramatically lower soft tissue complications and tend to be more cosmetically acceptable to patients.⁵ Unfortunately, transcutaneous devices typically suffer soft tissue attenuation of high frequency sound and contact feedback issues.^6,7

To address this, active trans-cutaneous BCDs/BAHAs have been developed. In these systems (eg, Med-El Bonebridge^©, Cochlear^TM Osia^©), an external processor communicates transcutaneously via radiofrequency with an implanted active transducer. Through this technology, bone conduction of sound can occur with significantly reduced sound attenuation and feedback distortion.^8-10

As of 2019, the Osia 2 active transcutaneous system has been approved for use in patients >12 years old in the United States. This system, while similar to other active transcutaneous systems, employs unique sound generation technology (powered piezoelectric system). Preliminary studies assessing the safety and efficacy of this device have reported good outcomes. However, a definitive study to synthesize the available literature on operative findings and surgical outcomes is lacking. The purpose of this study was to develop a comprehensive systematic review to evaluate the clinical performance of the Osia 2 system and to define outcomes reporting in patients >12 years old.

Methods

Search Criteria

The study was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.¹¹ A prospective protocol was registered with Prospero (CRD42023418393). A comprehensive literature search was performed in 4 databases: PubMed (U.S. National Library of Medicine, National Institutes of Health), Scopus (Elsevier), Cochrane CENTRAL, and CINAHL (EBSCO). The search strategy utilized both subject headings (eg, MeSH in PubMed) and keywords for the following concepts and/or keywords: bone conduction, bone conduction devices, bone-anchored hearing aids, active transcutaneous implant, osseointegrated steady-state implant, Cochlear™ Osia^® OSI200 System (Osia 2). The search strategies are outlined in Supplemental Appendix A. Databases were searched from 01/01/2019, through 4/12/2023. The reference lists of relevant and citing articles were manually searched to identify additional articles and confirm the search strategy. All references were uploaded to review management software Rayyan¹² and screened for inclusion in this study.

Selection Criteria

All clinical research studies involving human subjects implanted with the Osia active, transcutaneous, osseointegrated steady-state implant were considered. The following inclusion criteria were required for further abstract consideration: clear mention of surgical outcomes, intraoperative findings, audiometric outcomes and/or adverse events and complications. Exclusion criteria included non-English studies, non-human studies, cadaveric studies, prior reviews, and meta-analyses.

Titles and abstracts were first independently screened by 2 reviewers (C.C.M. and A.J.) to select for records that met inclusion criteria. Disagreements were resolved with a third reviewer (S.M.S.). Full texts were independently assessed by both C.C.M. and A.J. to identify which reports satisfied all the inclusion and exclusion criteria to be included in the final analysis. S.M.S. resolved any conflicts. The level of evidence for each selected study was evaluated with the 2011 criteria of the Oxford Center for Evidence-Based Medicine.¹³

Data Extraction

Two reviewers (C.C.M. and A.J) independently extracted the data and compared it for accuracy. Author, year of publication, country of study, study funding, and demographics, including age and gender were recorded. Other historical variables included type of hearing loss, otologic history, and prior hearing aid use were collected. Surgical characteristics extracted included operative time, incision type, incision length, soft tissue thickness, and need for soft tissue reduction or bone polishing. Adverse events/complications were recorded. Audiometric outcomes extracted included preoperative to postoperative improvement in pure tone average (PTA), individual frequency gains postoperatively (including 6 and 8 kHz), and preoperative to postoperative improvement in speech recognition threshold (SRT) and speech recognition score (SRS). PTA4 gain (0.5, 1, 2, and 4 kHz) was reported when available. Some studies used different frequencies for PTA gain, which is specified and reported in Table 4.

Data Analysis

Categorical variables were described by frequency and percentage. Continuous variables are included as mean and standard deviation (SD). Weighted means of certain outcome variables are reported to summarize findings across included studies, yet true meta-analysis was limited by the high heterogeneity in study design and in reported outcome measures and was therefore not performed in this systematic review.

Results

Search Results and Study Characteristics

The literature search yielded 836 unique articles. Title and abstract screening excluded 762 articles. A full text review was conducted of the remaining studies. Figure 1 outlines the full search process. Descriptive features of the included studies are summarized in Table 1. Articles selected for inclusion were between level 2 and level 4 studies based on the Oxford Level of Evidence¹³ and were published between 2020 and 2022 from 10 different countries.

Table 1.

Study Characteristics.

Study	LOE	Country of origin	Study design	Population	Total patients (Osia)	Age (y) mean (SD)	Male	Female	Comparator group
Briggs 2022¹⁴	3	Australia	Prospective	Adult	29	46.7 (19.7)	13	16	BAHA Softband
Cushing 2022¹⁵	3	Canada	Prospective	Pediatric	42	10.9 (4.1)	21	21	x
Florentine 2022¹⁶	4	USA	Retrospective	Pediatric	14	11.3	10	4	x
Gawecki 2020¹⁷	3	Brazil	Prospective	Adult	4	58	NR	NR	BAHA
Goldstien 2021^{18 a}	4	USA	Control Market Release	Adult	6	65.3	4	2	BAHA Attract BAHA Connect
Goldstien 2021¹⁸	4	USA	Case Control	Adult	43	44	NR	NR	x
Gordon 2020¹⁹	3	Canada	Initial Trial/Prospective	Pediatric	14	14.4 (2.2)	6	8	x
Goycoolea 2020²⁰	3	Chile	Prospective	Adult	9	35.3 (19.3)	2	7	BAHA Softband
Kim 2020²¹	3	Germany	Prospective	Adult	17	50.9 (18.5)	NR	NR	x
Lau 2020²²	3	UK	Prospective	Adult	10	52 (15)	5	5	x
Marszal 2021²³	2	Poland	Prospective	Adult	4	58	3	1	x
Mylanus 2020²⁴	3	Australia	Prospective	Adult	51	47.4 (14.7)	27	24	x
Pla-Gil 2021²⁵	3	Spain	Prospective	Adult	10	63.3 (7.7)	NR	NR	BAHA Power Connect 5
Quimby 2022²⁶	4	USA	Retrospective	Adult	23	51.9 (16.2)	11	12	x
Rauch 2021²⁷	3	Germany	Prospective	Adult	22	45.2	13	9	X
Shwam 2022²⁸	4	USA	Retrospective	Adult	11	NR	NR	NR	BoneBridge
Szabo 2022²⁹	4	Hungary	Prospective	Adult	5	NR	4	1	BAHA Attract
Willenborg 2021³⁰	3	Germany	Prospective	Adult	6	53.2 (5.2)	3	3	x
You 2022³¹	4	Canada	Retrospective	Pediatric	16	12.9 (2.4)	5	11	x

Goldstien (2021) reported on 43 patients for adverse events, and 6 for audiological outcomes.18

Baseline Characteristics

Eighteen studies were ultimately included in this systematic review comprising 336 patients. A total of 320 patients had their age reported with the mean age being 38.7 years (5-72 years). 251 patients had gender reported. 50.5% were male and 49.4% were female. All 18 studies reported on type of preimplantation hearing loss; 79.5% of patients had mixed or conductive hearing loss (MHL/CHL), 19.5% had single-sided sensorineural deafness (SSD), and 1.0% were classified as other. Fourteen studies reported on otologic history, which was broken down into three categories: congenital/malformation, infectious, and not categorized. The most common history was aural atresia (27.1%; without microtia 15.6%, with microtia 11.5%), followed by chronic otitis media (22.3%), and other (12.8%). About 89.2% and 10.8% of implantations were unilateral and bilateral respectively (Table 2).

Table 2.

Patient Characteristics.

Type of hearing loss	n = 293	%
MHL/CHL	233	79.52
SSD/SHL	57	19.45
Other	3	1.02
Etiology of hearing loss	n = 243
Congenital/malformations
Atresia only	38	15.64
Microtia and atresia	28	11.52
Canal stenosis	10	4.12
Cochlear nerve aplasia	8	3.29
Ossicular dys/aplasia	3	1.23
Enlarged vestibular aqueduct	3	1.23
Microtia	3	1.23
Malformations	2	0.82
Congenital deafness	2	0.82
Congenital fixation of stapes	1	0.41
Infections
Chronic otitis media	55	22.63
Chronic ear infection	24	9.88
Mastoid cavity	13	5.35
Otitis media with effusion	8	3.29
Cholesteatoma	4	1.65
Labyrinthitis	1	0.41
Meningitis	1	0.41
Not categorized
Other	31	12.76
Otosclerosis	4	1.65
Unknown	4	1.65
Tumor	3	1.23
Trauma	2	0.82
Acquired stenosis of EAC	2	0.82
Chronic middle ear disorder	2	0.82
Medial canal fibrosis	1	0.41
Bilateral versus unilateral osia implant	n = 194
Unilateral	173	89.18
Bilateral	21	10.82
Previous hearing aid use	n = 91
Yes	48	52.75
No	43	47.25
Surgical history	n = 50
Tympanomastoidectomy	17	34.00
Microtia/atresia reconstruction	9	18.00
None	8	16.00
Mastoidectomy	4	8.00
Tympanoplasty	1	2.00
Meatoplasty	1	2.00

Five studies had information on previous hearing aid use, with 52.8% of patients fit with a device for at least 6 months preimplantation. Four studies reported on preimplantation surgical history. Of patients in this cohort, 84% had undergone a previous otologic surgical procedure with breakdown as follows: tympanomastoidectomy (34%), microtia/atresia repair (18%), or mastoidectomy (8%; Table 2).

Surgical Data

Twelve studies reported on operative time, resulting in an overall mean of 71.6 minutes. Incision type was reported in four studies, with 54.8% receiving a “C” shaped incision, 36.9% receiving an “S” shaped incision, and 6.0% of patients undergoing an alternative/horizontal incision. Incision location with respect to the bone implant location was recorded in seven studies. 73.6% had a post-auricular anterior location, 17.8% had a post-auricular posterior location, and 3.1% had a posterior superior location. Location is reported with respect to the bone implant site. Four studies reported on mean soft tissue thickness at the magnet site which was 6.0 ± 1.5 mm. Ten studies reported on surgical performance of soft tissue thinning/reduction at the time of initial implantation, which was performed at an overall rate of 6.4%. Nine studies reported on bone-bed polishing, which was performed in 43.7% of cases (Table 3).

Table 3.

Surgical Characteristics and Adverse Events.

Surgical characteristics	(n)	%	Adverse events (n = 303 patients)	(n)	%
Average time (n = 248)	71.62 min		Total adverse events	61	20.13
Incision type (n = 84)			Postoperative Infection	15	4.95
C	46	54.76	Postoperative pain	10	3.30
S	31	36.90	Poor magnet retention	6	1.98
Alternative	5	5.95	Swelling/inflammation	5	1.65
Anterior slightly curved	1	1.19	Hematoma	5	1.65
Curvilinear C shape	1	1.19	Vertigo	3	0.99
Incision location (n = 163)			Warmth at SP site	3	0.99
Anterior	120	73.62	Headache	3	0.99
Posterior	29	17.79	Irritation	3	0.99
Posterior superior	5	3.07	Bleeding	2	0.66
Waist/prior	5	3.07	Buzzing/vibration	2	0.66
Complex	2	1.23	Numbness after surgery	2	0.66
Other	2	1.23	Tension at Implant Site	1	0.33
Average soft tissue thickness (n = 64)	6.0 mm (1.5)		Displacement of device magnet	1	0.33
Bone polishing/reduction (n = 213)	93	43.66
Soft tissue reduction (n = 218)	14	6.42
			Management of adverse events
			Infections that required antibiotic treatment	13	86.67
			Required reoperation	1	0.33
			Explant	3	0.99
			Revision/reimplantation	1	0.33

Audiometric Outcomes

Sixteen studies reported audiometric data. There was considerable heterogeneity in reporting standards limiting pooled analysis of outcome measures. PTA gain (preoperative to postoperative) was the most frequently reported metric. However, a high degree of variability was also encountered in the methodology of audiometric data collection. For instance, preoperative PTA in some studies was reported only for unaided conditions, while other studies reported preoperative PTA as aided bone conduction thresholds utilizing a BAHA softband. In studies (14) reporting postoperative PTA gain with Osia compared to preimplantation unaided condition, patients experienced an overall improvement of 35.4 dB (weighted mean; Range: 28.4-58.5 dB; Table 4). Five studies reported on postoperative gain at individual high frequencies (6 kHz and above). Following Osia implantation, patients achieved a mean BC-threshold improvement of 16.1 dB (Range: 13.9-50 dB) at frequencies >6 kHz when compared to preoperative, BAHA soft band aided thresholds. Six studies reported on SRT, with a mean improvement of 19.1 dB with Osia compared to unaided conditions. Mean SRT improvement with Osia compared to preoperative aided conditions was 9.4 dB. Nine studies reported on SRS, with an average improvement of +59.7% compared to unaided conditions (Table 4).

Table 4.

Audiometric Outcomes.

Study	PTA gain from unaided, mean (SD)	High frequency improvements, mean (SD)	Improvement in SRT, mean (SD)	Change in SRS, ∆% (SD)	Notes
Briggs 2022	28.4 dB	At 6 k Hz, 36.1 dB from unaided and 13.9 dB from aided	8.8 dB (7.9) from unaided conditions	+54.0% (29.8)	6 mo follow-up data; WRS in quiet at 65 dB; aided comparator was a Baha 5 Power on a Softband. PTA: 0.5, 1, 2, and 3 kHz.
Cushing 2022	—	—	—	—	No audiometric results reported.
Florentine 2022	NR	At 8 kHz, improvement from aided preop 42.5 dB (10.6) to 23.8 dB (7.5) with Osia	—	—	Overall postop aided PTA 26.2 dB (2.5) for n = 10, compared with unaided preop PTA of 69.7 (9.4) for atresia pts and 108 dB for 2 SSD pts. PTA: 0.5–4 kHz.
Gawecki 2020	42.8 dB (4.9)	—	—	—	Compared with other BCD implanted pts gain of 38.8 (8.5).
Goldstein 2021	58.5 dB	At 6 kHz, Osia outperformed Baha Attract by 19.3 dB and Baha Connect by 15.3 dB	—	+57.0%	PTA4 gain better than Attract (9.6 dB) and Connect (10.2) for n = 6; CNC word score list for SSD subgroup n = 4.
Gordon 2020	31.5 dB (1.6)	—	—	+77.3%	PKB scores at 65 dB; PTA: .5, 1, 2, 3, 4 kHz.
Goycoolea 2020	36.9 dB	—	9.5 dB compared to aided	+9.6% at 2 mo, +21.0% at 6 mo	Functional gain values calculated from 250 Hz to 6000 Hz; Aided comparator was a Baha 5 Power on softband; gain for Baha of 30.6 dB; Speech scores from Speech in noise S/N = 0.
Kim 2020	NR	—	—	—	11.1 dB (14.9) better than aided at 2 kHz, 37.5 dB (8.9) better at 6 k z. Aided comparator - Baha 5 SuperPower on softband.
Lau 2020	39.4 dB (28.3)	—	15.4 dB from unaided conditions	—	Provides subgroup data for SSD, MHL, and CHL groups; greatest PTA4 gain seen for SSD patients with improvement of 86.5 dB (10.6).
Marszal 2021	51 dB (4) at 6 mo.	At 6 kHz, Osia was 19 dB (8) better than Baha on softband	—	+61.3% at 65 dB in quiet, +85.0% at 65 dB in noise	All pts reported >8 hours daily use; 6-mo follow ups utilized, 9-mo, and 12-mo data available.
Mylanus 2020	30.4 dB (8.9)	—	13.6 dB from unaided conditions7.5 dB compared to aided	+68.3% at 65 dB in quiet	Follow-up data at 12 mo; PTA4 gain outperformed Baha on softband comparison by 22.8 dB; has data for subgroups of MHL/CHL vs SSD.
Pla-Gil 2021	35.9 dB	4 kHz showed greatest difference: +49.5 dB for Osia, 65 dB for Connect pts.	—	+42.0% at 65 dB in quiet	Comparator provided with Baha Connect patients; Connect pts had of 30.6 dB; Connect patients had +43% SRS at 65 dB in quiet. PTA: 0.5, 1, 2, 3, and 4 kHz.
Rauch 2021	CHL group: 36.0 dB (5.2)	Increased improvement with increasing frequency vs. Baha on softband noted, significant at 6 kHz.	—	+65.8% for CHL/MHL pts with Osia 2 compared to BAHS	All pts reported >8 hrs/day use; SRS was Freidburg monosyllabic in quiet at 65 dB; data from 12-mo follow-ups; comparator was Baha on softband; CHL and SSD subgroups reported independently; reported both Osia 1 and Osia 2, only Osia 2 included here; significant improvement over comparator in CHL/MHL patients.
Szabo 2022	43.3 dB (7.9)	—	33.2 dB from unaided, 25.7 dB from aided	—	15.5 dB gain more than BAHA Attract.PTA: 0.25, 0.5, 1, 2, and 4 kHz.
Willenborg 2021	31.5 dB	—	—	+92.0%	All pts SSD; After 6 wk, 4 pts wore from 8–16 h/d, 1 wore 2–3 h/d; SRS was FR MS at 65 dB in quiet.
You 2022	43.1 dB (10.2)	Largest improvement (>50 dB) was seen at 6 kHz	41.1 dB from unaided conditions	—	SRS data reported for various tests (NU-6, pediatric AzBio, adult AzBio, CNC, etc. but not pooled. PTA: 0.5, 1, 2, and 3 kHz.
Schwam 2022	—	—	—	—	Postoperative audiometry was not routinely performed.
Quimby 2022	37.8 dB	—	—	—	Preoperative SRS reported to be 84.2%, no postoperative SRS data reported. PTA: 0.5, 1, 2, and 3 kHz.
Mean	35.4 dB	16.1 dB	19.1 dB (unaided)9.4 dB (aided)	+57.9%	—

Note. PTA4 (.5, 1, 2, and 4 kHz) was reported when available, or as otherwise listed in “Notes.”

Abbreviation: PTA, pure tone averages.

Complications/Adverse Events

Sixteen studies reported on post-surgical adverse events (also listed as complications), with 61 total events tabulated (Table 3). Of the 303 patients comprising these studies, 5.0% experienced postoperative infections, 3.3% had excessive postoperative pain, 2.0% experienced persisting magnet problems (retention, tissue complications), and 1.7% experienced hematomas. Cases of infections typically required oral antibiotic treatment and responded well. Surgical re-exploration was rare, occurring in 0.3% of patients. About 1.0% required explantation, although roughly one-third of those patients were reimplanted at a later date.

Discussion

The Osia 2 active transcutaneous BCD has now been FDA-approved since 2019 in the US (age >12 years) for patients with CHL, MHL, or SSD. This systematic review sought to synthesize the available literature pertaining to clinical, audiologic, and surgical presentations/outcomes with this device. Ultimately, 18 studies met inclusion criteria with cohort sizes ranging from 5 to 51 patients. Although small in size, numerous studies included in this review were prospectively designed with well reported methodology and clear outcomes reporting. Reporting on clinical presentations, surgical findings, and surgical outcomes was widespread. Conversely, audiometric data was highly heterogeneous in terms of both reporting and methodology of conduct.

The scope of this review was intentionally limited to studies investigating the Osia 2. Although there are other active transcutaneous BC implants available to patients on the market (eg, Med El Bonebridge©), the piezoelectric transducer design, anatomical location of bony implantation, and size/shape of the Osia implant are unique. Thus, it was felt that a direct comparison of surgical findings and operative outcomes between Osia and other devices would be difficult and likely flawed.

In this review, both adolescent and adult data were aggregated in our synthesis. The investigators felt the anatomical maturity of the temporal bone and auricular tissues in adolescents (age 12-21 years) is so close to that of adults (age >21 years) that age-related data grouping would not be warranted to meet the objectives of this study.³² It was also felt that adolescent patients would be capable of completing the same behavioral audiometric outcomes testing as adults. One potential limitation of this study design could be in the reporting of complications and adverse events, as adolescents would be more likely to participate in strenuous and contra-indicated activities postoperatively. Investigating this, our group did not find any significant differences in complications between these age groupings (data not shown).

At the time studies included in our review were published, the Osia device was only FDA-approved for ages >12 years. As such, most of the pediatric data included in this study was from institutions outside of the USA. Notably, these studies did tend to report on older children and adolescents (mean age 11.9 years). Additional systematic reviews or meta-analyses may be required in the future to better evaluate implant performance and metrics in the pediatric population. This should soon be feasible given the recent FDA-approved age expansion for Osia implantation in children ages 5 to 11 years in spring 2024.

Recipients of the Osia 2 system underwent surgery for similar indications as patients receiving other forms of BCDs. Nearly 4/5 patients in our study were being treated for MHL/CHL, which is the most common type of hearing loss indicating other BCD systems.³ Approximately 40% of cases in this investigation had reported congenital malformations (most often aural atresia), while 43% had a history of chronic ear disease and/or cholesteatoma. Interestingly, a large percentage of patients (84%) had previously undergone some type of otologic surgery. This could be of relevance when interpreting some of these data, especially those regarding adverse outcomes. Additionally, while Cochlear™ recommends a post-auricular “S” shape incision, the majority of patients in our review received a “C” shape incision. This may have been predicated due to high prior-operation rates.

For studies reporting such data, the mean operative time for the Osia 2 system was notably >70 minutes (Range: 52-119 minutes). This would be considered longer than surgeries for other BCD systems, although precise figures for comparison are lacking in the literature. This likely relates to the relatively high number of cases that required drill-polishing of the bony implantation site (~44%) and to added time in cases requiring tissue reduction around the magnet area (6%).³³ Longer surgical times could also be related to some early unfamiliarity with the operative procedure amongst surgeons, in turn owing to the relatively new nature of this implant system in the US (2019) and a market rollout delayed by the global pandemic in 2020 and insurance coverage issues. The authors of this investigation speculate that operative times will likely shrink over time as surgeons become more familiar with the procedure. Collection of operative time data is also inherently biased and difficult to standardize, so these data should be interpreted with caution.

While there was significant heterogeneity in the methods and reporting of audiometric data, the Osia BCD was found to be associated with significant improvements in PTA, high frequency thresholds, and SRT. There was also notable improvements in BC thresholds with Osia compared to other forms of preimplantation aided-BC hearing (BAHA softband). This is a noted potential benefit of active, transcutaneous implants as they are capable of avoiding skin attenuation and reduced high frequency gain.³⁴

Additionally, speech recognition scores (SRS) were shown to significantly improve following Osia implantations compared to a preoperative unaided condition. Speech perception outcomes presented in this review should be interpreted with caution, however, as included studies often utilized different word/sentence lists, variable follow-up time-points, and disparate comparators (eg, unaided versus aided conditions). When assessing hourly usage and overall usage rates of the Osia 2 device, such data was not often reported. The available data suggested an aggregated mean 9.6 hours/day usage rate, comparable to the 11.2 use-hours per day reported for another active, transcutaneous BCD.³⁴

In this study, adverse event (complication) rates were somewhat high (20.13%), although the rate of major postoperative complications (infection, hematoma) was low. These figures likely reflect the transparent reporting of the studies included in this review and likely are a good estimation of the true incidence of adverse outcomes following Osia 2 implantation. Compared to percutaneous BCDs, which have reported complication rates as high as 59%,³⁵ the Osia 2 system would have a significantly lower overall adverse outcome rate. In a systematic review by Souza et al. (2022),³⁶ transcutaneous devices (all types) were associated with an overall complication rate of 21.3%, which would be comparable to the rates reported in this review. As the literature pertaining to the Osia 2 system evolves, rates of postoperative infection, magnet retention, and hematoma will need to be monitored and would be expected to decline. While each outcome individually did not have a high incidence, re-operations were required on rare occasions.

At the time of this investigation, 1 meta-analysis has been published on the Osia device, synthesizing audiometric outcomes across studies.³⁷ This study, published by Key et al,³⁷ was a well-conducted investigation focused primarily on audiometric gain measures and (audiometric) patient -reported outcomes measures. While that investigation does perform some limited reporting on operative indications and outcomes, the scope and extent of data reporting was significantly narrower than what is presented in the present investigation. To our knowledge, the present systematic review is the only one of its kind to synthesize intra-operative data such as bone bed polishing, soft tissue thinning and operative time, and is the only literature synthesis to comprehensively explore postoperative adverse events.

This study has inherent limitations due to being a systematic review and the quality of evidence provided by studies included in the review. Data collection was dependent on the reporting methodology in each individual study, and aggregate data comparisons were limited by the heterogeneity of the data available (see section on Audiometric outcomes). Further, adverse events reporting should be interpreted with caution, as some investigations did not report on adverse events, and the definition of adverse events/complications overall lacked standardization. This review illustrates the need for standardization of data reporting in future studies pertaining to the Osia 2 BCD.

Conclusion

Overall, the current body of literature on assessing the Osia 2 BCD suggests that it is safe and effective for its intended indications. Comparisons with other BCDs should be made with caution given the unique features of this active transcutaneous system, but adverse events and performance metrics were overall comparable or better than other BCD systems. As surgeon experience with the device grows, and as more pediatric studies are published, follow up reviews will be warranted to augment data reported in this investigation.

Supplemental Material

sj-docx-1-aor-10.1177_00034894241283269 – Supplemental material for A Systematic Review of Surgical Characteristics and Adverse Events of an Active, Transcutaneous Bone Conduction Device

Supplemental material, sj-docx-1-aor-10.1177_00034894241283269 for A Systematic Review of Surgical Characteristics and Adverse Events of an Active, Transcutaneous Bone Conduction Device by Alma Jukic, Christopher C. Munhall and Shawn M. Stevens in Annals of Otology, Rhinology & Laryngology

Footnotes

Acknowledgements

None.

Author Contributions

Alma Jukic: Study design, data extraction, analysis, drafting, and revision of manuscript; Christopher C. Munhall: Study design, data extraction, analysis, drafting, and revision of manuscript; Shawn M. Stevens: Conception of idea, study design, data extraction, analysis, drafting, and revision of manuscript.

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Shawn M. Stevens, MD: Cochlear Americas. Consultant. Speaker Honorarium. There was no direct or indirect conflict of interest or interaction with this entity regarding conduct of this investigation. No funding or other renumeration was received in association/support of this research. Zeiss. Consultant. Stryker Corporation. Consultant. Alcon Medical. Consultant.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Alma Jukic

Christopher C. Munhall

Shawn M. Stevens

Supplemental Material

Supplemental material for this article is available online.

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