Loading of osseointegrated implants for bone conduction hearing at 3 weeks: 3-year stability, survival, and tolerability.

The objective of this study was to ascertain the long-term safety of loading osseointegrated implants for bone conduction hearing 3 weeks post-surgery. Thirty consecutive adult patients were implanted with the Baha BI300 (Cochlear Bone Anchored Solutions) in our tertiary referral center. Implants were loaded with the sound processor 3 weeks post-surgery. Follow-up examinations were performed at 10 days; 3, 4, 6, 8, and 12 weeks; 6 months; and 1, 2, and 3 years after implant surgery. At each follow-up visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis, and soft tissue status was evaluated according to Holgers' classification. ISQ trends, implant survival, and soft tissue reactions were compared to a population of 52 patients with the same type of implants loaded from 6 weeks post-surgery as part of another study. Subjective benefit was measured by means of the Glasgow Benefit Inventory (GBI). After an initial dip in ISQ at 10 days after implantation, a gradually increasing trend in ISQ was found until 6 months in both populations, after which ISQ values remained above baseline values. Implant survival was 97 % in the study population and 96 % in the comparison population. Clinically relevant soft tissue reactions were found in 0.9 % (study population) and 1.7 % (comparison population) of all visits. Patients reported subjective benefit; the mean GBI score was 22.8. In conclusion, loading these implants at 3 weeks post-surgery is safe based on the current study, as long-term results show high ISQ values and good implant survival and tolerability.

Benefit of Baha in the elderly with single-sided deafness.

The objective of this study is to determine the benefits of bone-anchored hearing aid (Baha) contralateral routing of signal (CROS) in the older adult population with single-sided deafness. Five questionnaires [general usage questionnaire, Glasgow benefit inventory (GBI), Abbreviated profile of hearing aid benefit (APHAB), Nijmegen cochlear implant questionnaire and the hearing handicap inventory for the elderly-screening version (HHIE-S)] were used to evaluate Baha use. Consecutive patients over 60 years of age with SSD fitted with a Baha CROS between April 1990 and April 2007 not using a conventional hearing aid in the better-hearing ear were identified. Nine out of 11 patients (82 %) were still using their Baha CROS, and 7 of the 11 patients (64 %) were still satisfied. The patients experienced no to little problems with handling and cleaning of the device. The GBI scores show good benefit in domains total (14 ± 11) and general (19 ± 17). The APHAB shows that, overall, 3 out of the 11 patients (27 %) experienced significant benefit, while all others experienced no significant benefit and no drawbacks. The HHIE-S shows that the patients experienced severe (18 %), mild to moderate (46 %) or no handicap (36 %) when using the Baha CROS. In conclusion, the benefit of a Baha CROS for elderly patients with SSD is evident in the majority of patients.

Bone-anchored hearing implants in single-sided deafness patients: Long-term use and satisfaction by gender.

OBJECTIVES/HYPOTHESIS: To examine the long-term satisfaction and possible effects of gender in patients with single-sided deafness (SSD) who underwent bone-anchored hearing implant (BAHI) surgery. STUDY DESIGN: Retrospective case-control study. METHODS: All (n = 145) consecutive SSD patients fitted with a BAHI between January 2001 and October 2011 were asked to complete a questionnaire consisting of the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Communication Profile for the Hearing Impaired (CPHI), and the SSD questionnaire. RESULTS: Twenty-three of the 135 responding patients (17%) reported discontinuation of the device over an average follow-up time of 61.7 months. No significant differences were found in the degree of disability or coping between men and women, according to the APHAB and CPHI scores. Improvement in quality of life and appreciation of the BAHI were not affected by gender, age, directional hearing ability, and handling of the device. The appearance of the device positively affected their appreciation. At the mean follow-up time of 117 months, 69.2% was using their BAHI. In the domains background noise, reverberant surroundings, and aversion to sounds, the mean APHAB scores were significantly changed at 3 months, 1 year, and 10 years after implantation. CONCLUSION: Our study examined the results of BAHI use in SSD patients over a relatively long follow-up period, with an average of 5 years. The majority of users (83%) were satisfied with the device. No significant gender differences were in terms of reported appreciation, hearing disability, or coping with a BAHI. LEVEL OF EVIDENCE: 3b.

A Retrospective Cohort Study on the Influence of Comorbidity on Soft Tissue Reactions, Revision Surgery, and Implant Loss in Bone-anchored Hearing Implants.

OBJECTIVE: To identify risk factors for complications after bone-anchored hearing implant (BAHI) surgery. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary referral center. PATIENTS: All adult patients who received titanium bone-anchored hearing implants at our clinic between September 1, 1988 and December 31, 2007 were approached to fill out a questionnaire on comorbidity factors. A total of 581 patients with 669 implants were included in the analysis. MAIN OUTCOME MEASURES: Implant loss, soft tissue reactions, and revision surgery after BAHI implantation. RESULTS: Skin disease and profound learning difficulties were risk factors for time to first soft tissue reaction, hazard rate ratio of 3.41 (95% CI 1.45-8.01) and 3.42 (1.03-11.39), respectively. Female gender showed a trend toward a negative risk for time to first soft tissue reaction, hazard rate ratio 0.60 (0.35-1.03). In multivariable analysis, skin disease and female gender were observed as independent associative factors, adjusted hazard ratio 3.08 (1.32-7.16) and 0.56 (0.33-0.94). For revision surgery, female gender and cardiovascular disease were identified as negative risk factors in univariable analysis, and smoking showed a trend toward a negative risk, with hazard ratios of 0.15 (0.07-0.32), 0.07 (0.03-0.20), and 0.51 (0.24-1.07), respectively. In multivariable analysis, smoking and female gender were observed as independent associative factors, adjusted hazard ratio 0.45 (0.22-0.95) and 0.14 (0.06-0.30). Smoking could be identified as a risk factor for implant loss with a hazard ratio of 3.32 (1.36-8.09). CONCLUSION: Retrospective analysis of comorbidity factors and clinical outcomes revealed risk factors for postoperative complications after BAHI surgery.

Bone-anchored hearing implant loading at 3 weeks: stability and tolerability after 6 months.

OBJECTIVE: To clinically evaluate the performance of a titanium percutaneous bone-anchored hearing implant (BAHI) using a 3-week healing period. Short-term implant survival, stability changes, and skin reactions are evaluated from the initial implantation to 6 months postimplantation. METHODS: Thirty patients eligible for a BAHI were included in an open, prospective clinical investigation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis (RFA) at the time of implantation and at 10 days; at 3, 6, and 12 weeks; and at 6 months after placement of the implant. Sound processor fitting was performed 3 weeks after implantation. Skin reactions were evaluated according to the Holgers classification. RESULTS: One implant was lost 3 days after implantation because of poor bone quality. No implant loss occurred in the remaining 29 patients (96.7%). The mean ISQ value at the time of implantation was 67.1 (range, 44-71). Compared with baseline, there was a significant dip of -2.2 ISQ units at 10 days (mean, 65.7; p = 0.0093). There was a positive change in mean ISQ compared with baseline over the subsequent visits. No reduction in mean ISQ values was observed after implant loading. Skin reactions were observed incidentally (mean over all visits, 9.7%) and were generally mild (Holgers Grade 1; mean 9.0%). An adverse skin reaction (Holgers Grade 2) was observed only once (mean, 0.7%). CONCLUSION: The current study suggests that loading the implant and 6-mm abutment with the sound processor at 3 weeks is safe. The stability of the implant as measured by ISQ values had reached its baseline value within 3 weeks after implantation. The degree of stability was not affected by implant loading. Only mild skin reactions were observed incidentally. This study supports the use of early loading at 3 weeks as current practice in healthy adults with good bone quality; thus, these adults can benefit from the rehabilitation of their hearing at an earlier stage.

Analysis of factors predicting the success of the bone conduction device headband trial in patients with single-sided deafness.

OBJECTIVE: To determine factors predicting whether patients with single-sided deafness (SSD) opt for a bone conduction device (BCD) for the contralateral routing of sound (CROS) after a regular trial with a BCD on a headband. DESIGN: Retrospective case-control study. SETTING: Nijmegen, the Netherlands. PATIENTS: Thirty consecutive patients with SSD. INTERVENTIONS: Patients received a trial with a BCD headband as part of the regular workup for SSD. The patients were divided into 2 groups according to their decision to opt for a BCD (BCD+) or not (BCD-). MAIN OUTCOME MEASURES: Patients completed a questionnaire on satisfaction with the BCD headband, patient- and BCD-related factors, and benefit in listening situations. RESULTS: Fourteen patients (47%) chose a percutaneous BCD application after the BCD headband trial. Hearing loss of the contralateral ear at 4.0 kHz was significantly larger in the BCD+ group for bone and air conduction (P = .05 and P = .02, respectively). Patients in the BCD+ group experienced more problems in several listening situations and used the BCD headband more frequently than patients did in the BCD- group. CONCLUSIONS: Several individual factors influence the decision of patients with SSD to opt for a BCD. Hearing loss in the contralateral ear at high frequencies seems to be a relevant factor to predict the success of the BCD headband trial. It is advisable to offer all patients with SSD the option to participate in the BCD headband trial for at least 1 week and create a realistic expectation for patients based on their unaided subjective hearing handicaps.

Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival.

OBJECTIVE: This study assesses soft tissue reactions and implant stability of 1,132 percutaneous titanium implants (970 patients) for bone conduction devices (BCDs). In addition, it examines BCD usage and comparisons between different patient groups. STUDY DESIGN: Retrospective survey. Mean follow-up time of 4.6 years. SETTING: Tertiary care referral center. PATIENTS: The surveyed cohort was divided into 3 different age groups (children, adults, and the elderly). In addition, 4 groups with variable loading times (i.e., the time between placement of the implant and loading the BCD sound processor) were identified as well as a subgroup of patients with mental retardation. MAIN OUTCOME MEASURES: Soft tissue reactions around the percutaneous implants as classified by the Holgers grading system, implant failure, and revision surgery rates. RESULTS: In 95.5% of the 7,415 observations of 1,132 implants, there were no adverse soft tissue reactions. Implant loss was 8.3%. Significantly more soft tissue reactions and implant failures were observed in children compared with adults and the elderly (p < 0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p = 0.001). The loading time did not influence the occurrence of soft tissue reactions and implant survival rates. CONCLUSION: Children and patients with mental retardation are the most vulnerable to soft tissue reactions and implant losses. Additional and more frequent care needs to be given during outpatient consultations. Because loading as early as 3 to 5 weeks did not negatively affect skin reactions or implant survival, full BCD installation can occur earlier without risk.

Titanium fixtures for bone-conduction devices and the influence of type 2 diabetes mellitus.

OBJECTIVE: The aim of this study is to evaluate whether diabetes mellitus (DM) is a risk factor for titanium fixture loss in bone-conduction devices (BCDs) because of osseointegration failure. STUDY DESIGN: Retrospective case study. SETTING: Tertiary referral center. PATIENTS: All patients who received a BCD at Nijmegen between January 1, 1988, and December 31, 2007, were analyzed. The analyses were performed on 833 patients (993 implants) and a subpopulation of patients aged 40 years or older consisting of 641 patients (739 implants). METHODS: Patients received a questionnaire asking about the presence of DM at the time of implantation. Data concerning implant loss were retrieved from medical records and the Nijmegen BCD database. RESULTS: The total survival rate of the BCD implant in this population was 90.6%. The prevalence of DM was 9.3%. In the subpopulation of patients aged 40 years or older, the non-DM group lost 5.1% of their implants versus 14% of Type 2 DM patients, a statistically significantly difference (p = 0.003). Spontaneous loss, loss due to a Grade 4 Holgers skin reaction, and trauma accounted for 2.2% versus 4.7% (p = 0.13), 0.5% versus 2.3% (p = 0.1), and 0.6% versus 4.7% (p = 0.007), respectively, of implant losses in non-DM versus Type 2 DM patients. CONCLUSION: The prevalence of DM among the Nijmegen BCD population is higher than the general Dutch prevalence. A statistically significantly higher implant loss was observed during the study period for Type 2 DM patients than non-DM BCD wearers.

An overview of different systems: the bone-anchored hearing aid.

In the past 30 years, a large amount of clinical and audiological research on bone conduction hearing devices has been performed. In this review, we give a brief history of the developments in indications, surgical techniques and sound processors with respect to implantable bone conduction devices like the bone-anchored hearing aid or Baha. Starting with the use of Baha in patients with bilateral conductive or mixed hearing loss (HL), the indications for such devices have been extended to patients with unilateral HL, children and moderate mentally retarded patients. Bilateral fitting has been shown to be beneficial in restoring binaural hearing in patients with bilateral acquired or congenital conductive HL. In addition, the surgical techniques used to implant the titanium fixture for Baha application have been modified and further developed to reach two main goals: (a) optimal osseointegration, and (b) preparation of the implant site to minimize the occurrence of soft tissue reactions. Currently, the most used techniques are the pedicled skin flap, dermatome and linear incision techniques. Several generations of the Baha(®) sound processor have been developed by Cochlear(TM) to provide sufficient amplification in different hearing situations. Improvements in sound quality, aesthetics and handling have been major points of interest. The Baha sound processors most often used today are the Baha(®) Divino, the Baha(®) Intenso and the Baha(®) Cordelle. Recently, the more flexible Baha(®) BP100 sound processor was launched.

Bone-anchored hearing aid implant location in relation to skin reactions.

OBJECTIVE: To evaluate the effect of implant location and skin thickness on the frequency and degree of adverse skin reactions around the abutment. DESIGN: Retrospective multivariate analysis of implant position related to skin thickness and clinical variables. SETTING: Tertiary referral center. PATIENTS: Random sample of 248 patients with bone-anchored hearing aids. INTERVENTIONS: Bone-anchored hearing aid implant placement by means of the linear incision technique. MEAN OUTCOME MEASURES: Type and number of skin reactions and implant loss. RESULTS: The mean (SD) distance from the external auditory ear canal to implant was 48.8 (8.0) mm (range, 29-84 mm). The mean skin thickness was 5.5 (1.9) mm. Severe skin reactions (Holgers classification, 2-4) were seen in 46 of the 248 patients (18.5%). Implant loss occurred in 4 patients (1.6%). Three implants were lost owing to failed osseointegration (1.3%), and another implant was removed because of deterioration of cochlear function (0.9%). No implant was lost as a result of infection. CONCLUSION: Implant location and skin thickness were not correlated with implant loss or the frequency or degree of adverse skin reactions around the abutment.