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Clinical Performance of a New Magnetic Bone Conduction Hearing Implant System: Results From a Prospective, Multicenter, Clinical Investigation

Briggs, Robert*; Van Hasselt, Andrew; Luntz, Michal; Goycoolea, Marcos§; Wigren, Stina; Weber, Peter; Smeds, Henrik*; Flynn, Mark; Cowan, Robert*

doi: 10.1097/MAO.0000000000000712
Prosthetic Devices
Open

Objective The aim of the investigation was to prospectively evaluate, in a multicenter setting, the clinical performance of a new magnetic bone conduction hearing implant system.

Methods The test device was the Cochlear Baha Attract System (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden). Instead of the skin-penetrating abutment of traditional bone conduction hearing implants, the test device uses an implantable and an external magnet to transmit sound from the sound processor (SP) through intact skin to the skull bone. Twenty-seven adult patients with a conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in the clinical investigation across four investigational sites. The patients were followed for 9 months after implantation. The study evaluated efficacy in terms of hearing performance compared with unaided hearing and with hearing with the SP on a softband. Patient benefit, soft tissue status, device retention, and safety parameters were monitored continuously throughout the investigation.

Results Surgery and healing was uneventful. Statistically significant improvements in audibility and speech understanding in noise and quiet were recorded for the test device compared with preoperative unaided hearing. Speech recognition was similar or better than tests performed with the same SP on a softband. Good soft tissue outcomes were reported, without major pressure-related complications. At the end of the investigation, all patients continued to use and benefit from the device.

Conclusion The test device provides good hearing performance in patients with a conductive hearing loss or single-sided sensorineural deafness, with good wearing comfort and minimal soft tissue complications.

*HEARing Cooperative Research Centre, Melbourne, Australia; †Chinese University of Hong Kong, Hong Kong, China; ‡Bnai Zion Hospital, Haifa, Israel; §Clínica Las Condes, Santiago, Chile; ∥Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden; and ¶Cochlear Americas, Denver, Colorado, U.S.A.

Address correspondence and reprint requests to Robert Briggs, The Royal Victorian Eye and Ear Hospital, 32 Gisbourne St, East Melbourne, Victoria 3002, Australia; E-mail: rjbriggs@netspace.net.au

S. W. and M. F. are employees of Cochlear Bone Anchored Solutions AB, and P. W. is an employee of Cochlear Americas. All other authors disclose no conflicts of interest.

The investigation was sponsored by Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden.

This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

Bone conduction hearing implants consist of a sound processor (SP) that transforms sound into vibrations, which are transferred via an osseointegrated implant to the skull bone and onward to the cochlea. Bone conduction hearing implants that rely on direct bone conduction via a skin-penetrating abutment have proven successful for patients with conductive/mixed hearing loss and single-sided sensorineural deafness (SSD) (1). The clinical reality, however, is that a relatively large proportion of potential candidates refuse the treatment, often because of esthetic concerns related to the skin-penetrating abutment (2–5). Other patients may, for medical or other reasons, not be able to perform the daily cleaning that is needed to maintain a reaction-free skin penetration. A non–skin-penetrating solution, with implantable components covered by intact skin, constitutes a viable option for this group of patients.

Non–skin-penetrating bone conduction hearing implants that use a magnetic coupling through the skin have been in clinical use for some time, with varying success (6,7). There are two main challenges associated with this type of device. First, energy loss in the intervening skin layer results in less effective sound transmission compared with direct bone conduction (8–10). However, recent advances in digital sound processing and fitting tools (11) make it possible to evaluate and partly compensate for sound attenuation by increasing the amplification in the affected frequencies (12). Second, the magnetic coupling must ensure good retention to enable effective sound transmission while not causing discomfort and/or pressure-related soft tissue complications.

A new magnetic bone conduction hearing implant system has been developed, which uses the same digital SP technology as for direct bone conduction as well as the same osseointegrating implant that has shown reliable stability in previous investigations (13–15). Instead of a skin-penetrating abutment, the new system relies on an implanted and an external magnet to retain the SP. A pad of soft material lines the external magnet and distributes the pressure across the skin surface. Research has shown that the combination of advanced sound processing, stable single-point fixation in the bone, and even contact pressure results in efficient sound transmission (16,17) and minimal skin complications (17).

The aim of the present investigation was to evaluate the clinical performance of the new magnetic bone conduction hearing implant system. The study evaluated efficacy in terms of hearing performance compared with unaided hearing and with hearing with the SP on a softband. Patient benefit, soft tissue status, device retention, and safety parameters were monitored throughout the investigation.

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MATERIALS AND METHODS

Investigational Sites and Patient Selection

This prospective, international, multicenter, clinical investigation included four sites: The HEARing Cooperative Research Centre (Melbourne, Australia), The Chinese University of Hong Kong (China), Bnai Zion Hospital (Haifa, Israel), and Clínica Las Condes (Santiago, Chile). The investigation was approved by local ethics committees and performed in accordance with the Declaration of Helsinki and international guidelines for Good Clinical Practice.

Adult patients with a conductive or mild mixed hearing loss in the ear to be implanted (bone conduction thresholds with pure-tone average [PTA] [mean of 500, 1,000, 2,000, and 3,000 Hz] of <30 dB hearing level [HL]) or with SSD (PTA <30 dB HL in contralateral ear) were included. Patient exclusion criteria included uncontrolled diabetes, condition that could jeopardize osseointegration and/or wound healing, too thin soft tissue, insufficient bone quality/quantity, and previous radiation therapy in the implant area.

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Test Device

The test device was the Cochlear™ Baha® Attract System (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden). The system consists of internal (surgically implanted) and external parts (Fig. 1). The internal parts comprise the osseointegrating BI300 Implant, onto which the titanium-encased BIM400 Implant Magnet is fixated. The external parts comprise the SP magnet onto which the SP attaches via a snap coupling. SP magnets with five different strengths—SPM1 (weakest) to SPM5 (strongest)—were available for the investigation to accommodate soft tissue thicknesses of 3 to 6 mm and to provide sufficient retention for different patient lifestyles. The SP magnet is lined with a soft pad made of slow-recovery foam that compresses and adapts to the underlying surface. All patients received the test device unilaterally.

FIG. 1

FIG. 1

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Surgery and Fitting

At the baseline visit before surgery, pure-tone audiograms, including masked/unmasked air- and bone conduction thresholds, were obtained. SP selection was based on patient preference and hearing tests with a Baha Softband. Patients received either the Cochlear Baha BP100 or the BP110 Power Sound Processor. After a home test period of 1 to 2 weeks using the SP on a softband, implant surgery was performed using the procedure recommended by the manufacturer. A C-shaped anterior incision, approximately 1.5 cm lateral to the planned margin of the internal magnet, was used. Periosteum was usually preserved around the osseointegrating implant. Implant stability quotient (ISQ) values (13,18) were obtained using resonance frequency analysis (Osstell ISQ, Osstell, Göteborg, Sweden). A bone-bed indicator was attached to the implant and rotated 360 degrees to ensure clearance over the adjacent bone; if required, periosteum and some bone were removed. The implant magnet was affixed to the implant using 25Ncm tightening torque. Before closure, the soft tissue flap thickness was measured; surgical thinning was advocated if the thickness exceeded 6 mm.

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Follow-up Examinations

Follow-up examinations were performed at 2, 4, and 6 weeks and 3 and 9 months after surgery. At 4 weeks, the patients were fitted with the SP magnet and SP. The retention force was measured using a dynamometer (Compact Force Gauge+, Slinfold, United Kingdom) at the time of fitting and at subsequent visits. Average and peak pressure between the magnet and underlying skin were measured using a pressure-sensitive sensor (I-Scan, Tekscan Inc., Boston, MA, U.S.A.).

Free-field hearing tests were performed in a soundproof audiometric chamber for the unaided situation and with the SP on a softband at the preoperative visit and with the test device 4 and 6 weeks and 3 and 9 months after surgery. All tests were performed with the nontest ear blocked by earplugs in case of normal/near-normal hearing in the nontest ear and with the signal processing of the SP set to omnidirectional mode. Pure-tone audiometry was performed according to the ascending Hughson-Westlake method with tones presented through a loudspeaker in the front position (0 degrees azimuth). Speech perception in quiet was evaluated using phonetically balanced words (monosyllabic/spondees) presented from the front. The test was performed at 50, 65, and 80 dB sound pressure level (SPL); scores were recorded as percentage correctly repeated words at each SPL. Adaptive sentence test in noise was conducted to establish the speech-to-noise ratio (SNR), providing 50% level of understanding. In Hong Kong and Santiago, language-specific versions of the Hearing in Noise Test (19) were used, with speech presented from the front and with noise from the back (Hong Kong) or from 45 degrees (Santiago). Noise was kept constant at 65 dB SPL, and speech was adapted in 2-dB steps. The adaptive Australian Sentence Test in Noise with Bamford-Kowal-Bench-like sentences (20) was used in Melbourne, but with adaptive speech and fixed noise to match the Hearing in Noise Test. In Haifa, the Hebrew version of the Central Institute for the Deaf Everyday Sentence Test (21) was used, with both speech and noise presented from the front (22) according to an adaptive tracking method.

The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire (23) was administered to the patients preoperatively and 3 and 9 months after implantation. The APHAB is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification.

The soft tissue at the surgical site was evaluated by the patient and investigator using the Patient and Observer Scar Assessment Scale (POSAS) (24). Patient reports of pain and numbness were collected. Daily usage time and any episodes of insufficient retention were recorded by the patient in a diary. Adverse events were monitored as per Good Clinical Practice.

The investigation was monitored by independent clinical research organizations. Data management was performed by independent data managers (dSharp, Göteborg, Sweden). Statistical analyses were performed by independent biostatisticians (Statistiska Konsultgruppen, Göteborg, Sweden) according to a predefined statistical analysis plan. For paired observations, Fisher’s nonparametric permutation test was used. Significance tests were two-tailed and conducted at the 0.05 significance level. All patients who received the test device were included in the analyses.

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RESULTS

Patients

Twenty-seven patients received the test device and were included in the investigation: eight patients in Melbourne, eight in Hong Kong, six in Haifa, and five in Santiago. Seventeen patients had a conductive hearing loss, and 10 patients had SSD. Demographics and baseline characteristics and mean baseline audiograms are presented in Table 1 and Figure 2. All patients attended all scheduled study visits.

TABLE 1

TABLE 1

FIG. 2

FIG. 2

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Surgery and Healing

Surgery was performed under general anesthesia and was uneventful in all patients. Good implant stability was achieved at insertion, with a mean ISQ of 75.7 (SD, 8.8) (mean of highest value out of two perpendicular measurements in each patient). The mean soft tissue thickness was 6.0 mm (SD, 1.1 mm). Flap thinning was performed in three patients. The average surgery time was 45.0 minutes (SD, 14.6 min) from first incision to last suture. The surgical site healed satisfactorily in all patients. No implants or implant magnets were lost, replaced, or removed.

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SP Fitting

Fitting of the SP to the magnetic implant was performed at 4 ± 1 weeks after surgery on all but one patient, for whom fitting was delayed 3 weeks because of trauma to the implant site 10 days after surgery. Six and 21 patients selected the BP100 and BP110 Sound Processor, respectively. Table 2 shows the distribution of SP magnets per visit. After initial magnet selection, 14 patients changed to weaker and two patients to stronger magnets. Four patients changed magnets more than once.

TABLE 2

TABLE 2

Insufficient magnetic retention was reported for five patients with SPM5, who all had preoperative soft tissue thicknesses exceeding 6 mm; in three of these patients, flap thinning was performed at implant surgery. Sufficient retention force was achieved by removing the soft pad while awaiting availability of a stronger magnet. Three of the patients were able to return to using the soft pad after a period of adaptation of the skin.

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Free-field Hearing Tests

Pure-tone audiometry showed a statistically significant improvement in PTA (mean of 500, 1,000, 2,000, and 4,000 Hz) of 18.4 dB HL (SD, 6.9 dB; p < 0.0001) with the test device at 9 months compared with unaided hearing. The corresponding improvement for the subgroup of patients with conductive hearing loss and SSD was 17.9 dB HL (SD, 6.6 dB; p < 0.0001) and 19.1 dB HL (SD, 7.7 dB; p = 0.0005), respectively. No statistically significant difference in PTA compared with softband tests was recorded. Table 3 shows PTA values per visit for all tested conditions.

TABLE 3

TABLE 3

Statistically significant improvements with the test device compared with unaided hearing were recorded at all frequencies up to and including 6,000 Hz (Fig. 3A). The mean improvement was largest in the frequency range 500 to 3,000 Hz: up to 25.2 dB improvement (SD, 8.4 dB; p < 0.0001). Overall similar hearing thresholds were obtained with the SP on a softband, with a slight advantage for the test device between 750 and 1,000 Hz and an advantage for the softband at and above 4,000 Hz.

FIG. 3

FIG. 3

Speech recognition tests in quiet showed statistically significant improvements at all tested intensity levels with the test device compared with unaided hearing. At 9 months, the mean improvement in percentage correctly repeated words at 50, 65, and 80 dB SPL was 50.0, 46.4, and 24.2 percentage points, respectively. Comparison with softband tests showed no significant differences (Fig. 3B). The percentage improvement for the subgroup of patients with a conductive hearing loss and SSD were similar: 55.6, 45.3, and 23.3 percentage points and 40.1, 48.3, and 25.8 percentage points, respectively, at increasing SPL.

A mean SNR of −4.9 dB (SD, 5.1 dB) was recorded for the test device in adaptive sentence in noise tests at 9 months, providing statistically significant improvements of 15.0 dB (SD, 12.8 dB; p < 0.0001) and 3.8 dB (SD, 7.0 dB; p = 0.0092) compared with unaided hearing and softband tests, respectively. A slight gradual improvement in SNR from the time of initial fitting to the 3-month follow-up visit was recorded (Fig. 3C). Although there were differences in test language and methodology, the four study sites were all consistent in terms of the improvement compared with both unaided and softband conditions. Similarly, results per type of hearing loss were in line with the global score. The SNR improvement compared with unaided hearing was 17.9 dB (SD, 15.2 dB; p < 0.0001) for patients with conductive hearing loss and 10.2 dB (SD, 4.7 dB; p = 0.002) for patients with SSD and 3.8 dB (SD, 7.6 dB; p = 0.05) and 3.7 dB (SD, 6.1 dB; p = 0.09), respectively, compared with softband.

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APHAB

Statistically significant improvements with the test device compared with the preoperative unaided situation were obtained for the APHAB subscales Reverberation (p = 0.016), Background noise (p = 0.035), and the Global score (p = 0.038). A nonsignificant improvement and a nonsignificant deterioration were recorded for the subscales Ease of Communication and Aversiveness, respectively (Fig. 3D).

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Magnetic Force and Pressure

The mean magnetic retention force across all visits was 0.99 N, with a relatively large variation between patients (SD, 0.23 N); the mean force remained stable across time (Table 3). The mean pressure between the SP magnet and the underlying skin remained relatively constant across time with an average of 0.14 N/cm2 (SD, 0.04 N/cm2) across all visits; no single value exceeded 0.4 N/cm2, which corresponds approximately to the capillary blood pressure. The mean peak pressure across all visits was 0.44 N/cm2 (SD, 0.27 N/cm2). For the patients who used the magnet with a soft pad, as indicated, the peak pressure did not exceed the target maximum value of 0.6 N/cm2 (corresponds approximately to the diastolic blood pressure in children), except at one or two occasions in three patients (only one of the recorded values exceeded 0.8 N/cm2, which approximates to the diastolic blood pressure in adults). In patients, who used SPM5 without a soft pad, however, significantly higher values were recorded (up to 1.95 N/cm2).

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Daily Use and Retention

The patient-reported average daily use was 7.0 h/d (SD, 3.8 h/d) and ranged between 3.4 and 15.4 h/d. The daily use for the subgroups of patients with conductive hearing loss and SSD was 7.6 (SD, 4.0 h/d) and 6.0 h/d (SD, 3.3 h/d), respectively. Incidences of insufficient retention were rare and reported to occur on average less than once every third day during normal daily activities.

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Soft Tissue Status, Numbness, and Pain

Overall low and decreasing POSAS scores were recorded, indicating satisfactory soft tissue status. At the last visit, the mean overall opinion of the skin was rated as 1.52 (SD, 0.93) by the investigators and 1.81 (SD, 1.21) by the patients on a scale from 1 to 10, with low values indicating good outcomes. The proportion of patients experiencing numbness was highest at the time of initial fitting (62.9%) and decreased gradually thereafter (22.2% at the last visit). Overall mean pain scores were low, indicating no or limited pain in the majority of patients. See Table 3.

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Adverse Events

No cases of pressure-related skin necrosis or significant soft tissue reactions were reported. Four cases of mild erythema were reported. Three events resolved without medical treatment; in one patient, this was achieved by changing to a weaker magnet. The last case was reported as initiated at the time of the last visit and, hence, was ongoing at study end. Four cases of pain at the implant site were reported, two of which resolved within 1 week without treatment. Two patients reported mild/moderate pain after continuous use of the device. One patient reported discomfort in the magnet area, which resolved without medical treatment. No other device-related local adverse events were reported. All patients continue to use and benefit from the device.

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DISCUSSION

The investigation evaluated the clinical performance of a novel magnetic bone conduction hearing implant in 27 adult patients with conductive or mild mixed hearing loss or SSD. The study showed statistically significant improvements in hearing performance compared with unaided hearing and similar or improved outcomes compared with tests performed with the SP on a softband. No major pressure-related soft tissue complications were reported and no implants were lost or removed, suggesting that the device is efficacious and safe for the tested indication.

Magnetic bone conduction hearing implants have the advantage over skin-penetrating systems of providing improved cosmetics and eliminating the daily cleaning of the site (25). With modern SP technology, it is possible to obtain good sound transmission despite the soft tissue attenuation that is inherent to magnetic bone conduction hearing implants. Although the system must provide reliable retention of the SP to ensure good clinical outcomes, it should not cause irritation of the skin or discomfort. Threshold audiometry showed that the test device provides significant functional gain at all frequencies. The improvement is largest in the important speech frequency range up to and including 3,000 Hz. Above 3,000 Hz, the performance drops gradually as expected because of the soft tissue attenuation, which is known to mainly affect the high frequencies (26,27). It is anticipated that aided high-frequency thresholds could be improved further (particularly by prescribing more amplification in the high frequencies) by less conservative SP settings than were used in the present investigation. It would be expected, however, that some attenuation of sound through soft tissue will remain. In the sentence tests in noise, which represents the most difficult listening situation, significant improvement in SNR was recorded compared with unaided hearing and compared with softband tests. Speech recognition in quiet was significantly better than for the unaided situation and similar to softband. Although not statistically verified, a gradual improvement in speech understanding was noted up to the 3-month visit, followed by relatively stable levels. A possible improvement in hearing performance may be explained by adaptation as patients get used to the sound; it may also be an effect of fine-tuning of the SP by the audiologist. The fact that overall comparable outcomes were obtained with the SP on a softband as with the test device suggests that preoperative softband tests are a good predictor of the patient’s postoperative hearing performance; the importance of preoperative testing to achieve successful clinical outcomes has been reported by several authors (5,28,29).

APHAB scores showed that the test device provides good subjective benefit in terms of the patient’s listening experience compared with the unaided situation. Improvements were obtained for the subscales related to reverberation, background noise, and ease of communication. A nonsignificant deterioration was observed for the subscale aversiveness, which quantifies negative reactions to environmental sounds; slightly worse aversiveness scores are a known effect with hearing devices (30,31) and have been attributed to unwanted sound also being amplified (30).

Soft tissue complications were minimal, as reflected by good POSAS scores and only four reports of mild skin irritation. The result suggests that the test device is associated with significantly less adverse soft tissue reactions than implants involving a skin-penetrating abutment (32). Favorable pain and numbness scores together with a high mean daily use (7 h/d) suggest good wearing comfort. Some patients reported average daily use exceeding 15 h/d; however, other patients were only part-time users while still reporting good benefit from the device. The relatively lower usage time in some patients may be reflective of the non–skin-penetrating nature and flexibility of the device, which allows patients to easily attach the SP to the invisible implant site when exposed to challenging listening situations. The ease of use of the device may provide significant advantages for patients with disabilities and/or reduced dexterity.

As with any surgical procedure involving incising soft tissue, a certain degree of transient (or in some cases permanent) numbness can be expected. In the present investigation, gradually reducing numbness was reported. Possibly the degree of paresthesia could be further reduced by placing the incision superior rather than anterior to the planned magnet position.

Assessment of the magnetic retention showed that the patients on average chose a retention force of around 1 Newton. However, the variability between patients was relatively large and most likely relates to different comfort levels and lifestyles of individual patients. For the same reasons and because of different soft tissue thicknesses, the patients chose SP magnets of varying strength. More than half of the patients required a change of SP magnet at some point during the investigation. The majority of these patients changed to a weaker magnet, which suggests that the tissue gradually compresses under the load of the magnet during the initial period after fitting. Similar observations have been reported for other implants incorporating a magnetic coupling (33,34).

The reported rate of insufficient retention was low. A few patients experienced retention difficulties with the strongest available SP magnet (SPM5); sufficient retention was obtained by removing the soft pad to increase the magnetic force. Removing the soft pad may cause areas of higher peak pressure to appear on the skin, as demonstrated by pressure measurements performed in this investigation. To maintain a healthy implant site, peak pressure areas should be avoided because the blood supply in the soft tissue may be affected. Areas of high peak pressure were not seen in the presence of the soft pad, demonstrating its ability to distribute the pressure evenly. All patients with retention difficulties had preoperative soft tissue thicknesses greater than 6 mm, highlighting the importance of flap thinning if the thickness exceeds this value. The need for extra magnet strength also in patients who had flap thinning at surgery suggests the presence of transient postoperative swelling/edema in these patients. Although the majority of patients were successfully fitted with the available range of magnets, additional strength may be required in specific situations as a temporary or permanent solution; hence, the manufacturer has developed a stronger magnet (SPM6) to meet this need.

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CONCLUSION

The magnetic bone conduction hearing implant evaluated in the present investigation was shown to be safe and effective because it provides good hearing performance in patients with conductive and mild mixed hearing loss or SSD, with good wearing comfort and minimal soft tissue complications. Future investigations may be considered to address the question of maximum audiometric fitting range for these systems. Magnetic systems constitute a viable alternative for patients who cannot or will not use an implant system that involves skin penetration. Although the investigation was limited to adult patients, it is expected that the device is equally suited for pediatric patients who are candidates for bone conduction surgery.

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Acknowledgments

The following coinvestigators and audiologists are acknowledged for great contributions throughout the investigation: Michael Tong, Gordon Soo, Willis Tang, Terence Wong, and Joannie Yu (Chinese University of Hong Kong, Hong Kong, China); Amit Wolfovitz, Rabia Shihada, Noam Yehudai, Riad Khnifies, and Talma Shpak (Bnai Zion Hospital, Haifa, Israel); Gloria Ribalta, Raquel Levi, and Pilar Alarcón (Clínica Las Condes, Santiago, Chile); and Kerrie Plant and Michelle Knight (HEARing Cooperative Research Centre, Melbourne). Thanks also to Johan Blechert (Cochlear Bone Anchored Solutions AB) for ensuring a high-quality study conduct in compliance with applicable guidelines and regulations.

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REFERENCES

1. Snik AF, Mylanus EA, Proops DW, et al. Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl 2005; 195: 2–12.
2. Desmet J, Bouzegta R, Hofkens A, et al. Clinical need for a BAHA trial in patients with single-sided sensorineural deafness. Analysis of a BAHA database of 196 patients. Eur Arch Otorhinolaryngol 2012; 269: 799–805.
3. Burkey JM, Berenholz LP, Lippy WH. Latent demand for the bone-anchored hearing aid: the Lippy Group experience. Otol Neurotol 2006; 27: 648–52.
4. Andersen HT, Schrøder SA, Bonding P. Unilateral deafness after acoustic neuroma surgery: subjective hearing handicap and the effect of the bone-anchored hearing aid. Otol Neurotol 2006; 27: 809–14.
5. Faber HT, Kievit H, de Wolf MJ, Cremers CW, Snik AF, Hol MK. Analysis of factors predicting the success of the bone conduction device headband trial in patients with single-sided deafness. Arch Otolaryngol Head Neck Surg 2012; 138: 1129–35.
6. Gates GA, Hough JV, Gatti WM, Bradley WH. The safety and effectiveness of an implanted electromagnetic hearing device. Arch Otolaryngol Head Neck Surg 1989; 115: 924–30.
7. Siegert R, Kanderske J. A new semi-implantable transcutaneous bone conduction device: clinical, surgical, and audiologic outcomes in patients with congenital ear canal atresia. Otol Neurotol 2013; 34: 927–34.
8. Håkansson B, Tjellström A, Rosenhall U. Hearing thresholds with direct bone conduction versus conventional bone conduction. Scand Audiol 1984; 13: 3–13.
9. Håkansson B, Tjellström A, Rosenhall U. Acceleration levels at hearing threshold with direct bone conduction versus conventional bone conduction. Acta Otolaryngol 1985; 100: 240–52.
10. Snik AF, Bosman AJ, Mylanus EA, Cremers CW. Candidacy for the bone-anchored hearing aid. Audiol Neurootol 2004; 9: 190–6.
11. Flynn MC, Hillbratt M. Improving the accuracy of BAHA fittings through measures of direct bone conduction. Clin Exp Otorhinolaryngol 2012; 5: S43–7.
12. Flynn MC, Hedin A, Halvarsson G, Good T, Sadeghi A. Hearing performance benefits of a programmable power BAHA sound processor with a directional microphone for patients with a mixed hearing loss. Clin Exp Otorhinolaryngol 2012; 5: S76–81.
13. Dun CA, de Wolf MJ, Hol MK, et al. Stability, survival, and tolerability of a novel BAHA implant system: six-month data from a multicenter clinical investigation. Otol Neurotol 2011; 32: 1001–7.
14. McLarnon CM, Johnson I, Davison T, et al. Evidence for early loading of osseointegrated implants for bone conduction at 4 weeks. Otol Neurotol 2012; 33: 1578–82.
15. Faber HT, Dun CA, Nelissen RC, Mylanus EA, Cremers CW, Hol MK. Bone-anchored hearing implant loading at 3 weeks: stability and tolerability after 6 months. Otol Neurotol 2013; 34: 104–10.
16. Kurz A, Flynn M, Caversaccio M, Kompis M. Speech understanding with a new implant technology: a comparative study with a new non-skin penetrating BAHA system. BioMed Int 2014; 2014: 416205.
17. Işeri M, Orhan KS, Kara A, et al. A new transcutaneous bone anchored hearing device—the BAHA Attract System: the first experience in Turkey. Kulak Burun Bogaz Ihtis Derg 2014; 24: 59–64.
18. Sennerby L, Meredith N. Implant stability measurements using resonance frequency analysis: biological and biomechanical aspects and clinical implications. Periodontol 2000 2008; 47: 51–66.
19. Nilsson M, Soli SD, Sullivan JA. Development of the hearing in noise test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am 1994; 95: 1085–99.
20. Dawson PW, Hersbach AA, Swanson BA. An adaptive Australian Sentence Test in Noise (AuSTIN). Ear Hear 2013; 34: 592–600.
21. Davis H, Silverman SR. Hearing and deafness. New York, NY: Holt Rinehart & Winston, 1970.
22. Boyle PJ, Nunn TB, O’Connor AF, Moore BC. STARR: a speech test for evaluation of the effectiveness of auditory prostheses under realistic conditions. Ear Hear 2013; 34: 203–12.
23. Cox RM, Alexander GC. The Abbreviated Profile of Hearing Aid Benefit. Ear Hear 1995; 16: 176–86.
24. Draaijers LJ, Tempelman FR, Botman YA, et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg 2004; 113: 1960–5.
25. Tjellström A, Håkansson B. The bone-anchored hearing aid. Design principles, indications, and long-term clinical results. Otolaryngol Clin North Am 1995; 28: 53–72.
26. Verstraeten N, Zarowski AJ, Somers T, Riff D, Offeciers EF. Comparison of the audiologic results obtained with the bone-anchored hearing aid attached to the headband, the testband, and to the “snap” abutment. Otol Neurotol 2009; 30: 70–5.
27. Tjellström A, Håkansson B, Granström G. Bone-anchored hearing aids: current status in adults and children. Otolaryngol Clin North Am 2001; 34: 337–64.
28. Pennings RJ, Gulliver M, Morris DP. The importance of an extended preoperative trial of BAHA in unilateral sensorineural hearing loss: a prospective cohort study. Clin Otolaryngol 2011; 36: 442–9.
29. Zarowski AJ, Verstraeten N, Somers T, Riff D, Offeciers EF. Headbands, testbands and softbands in preoperative testing and application of bone-anchored devices in adults and children. Adv Otorhinolaryngol 2011; 71: 124–31.
30. Pfiffner F, Caversaccio MD, Kompis M. Comparisons of sound processors based on osseointegrated implants in patients with conductive or mixed hearing loss. Otol Neurotol 2011; 32: 728–35.
31. Boleas-Aguirre MS, Bulnes Plano MD, de Erenchun Lasa IR, Ibáñez Beroiz B. Audiological and subjective benefit results in bone-anchored hearing device users. Otol Neurotol 2012; 33: 494–503.
32. Wazen JJ, Young DL, Farrugia MC, et al. Successes and complications of the BAHA system. Otol Neurotol 2008; 29: 1115–9.
33. James AL, Daniel SJ, Richmond L, Papsin BC. Skin breakdown over cochlear implants: prevention of a magnet site complication. J Otolaryngol 2004; 33: 151–4.
34. Hough J, Himelick T, Johnson B. Implantable bone conduction hearing device: Audiant bone conductor. Update on our experiences. Ann Otol Rhinol Laryngol 1986; 95: 498–504.
Keywords:

Bone conduction; Bone conduction hearing implant; Clinical outcome; Hearing performance; Magnetic system; Osseointegration; Bone-anchored hearing aid; Baha

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