Outcome prediction for Bonebridge candidates based on audiological indication criteria

ObjectiveTo re-evaluate current indication criteria and to estimate the audiological outcomes of patients with Bonebridge bone conduction implants based on preoperative bone conduction thresholds.MethodsWe assessed the outcome of 28 subjects with either conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) who were undergoing a Bonebridge implantation. We used linear regression to evaluate the influence of preoperative bone conduction thresholds of the better/poorer ear, indication group, and language (German- and French-speaking patients) on aided sound field thresholds. In addition, aided word recognition scores at 65 dB sound pressure level were fit with a logistic model that included preoperative bone conduction thresholds of the better/poorer ear, indication group, and language as effects.ResultsWe found that both aided sound field thresholds and word recognition were correlated with the preoperative bone conduction thresholds of the better hearing ear. No correlation between audiological outcomes and the preoperative bone conduction thresholds of the poorer ear, language, or indication group was found.ConclusionBone conduction thresholds of the better hearing ear should be used to estimate the outcome of patients undergoing Bonebridge implantation. We suggest the indication criteria for Bonebridge candidates considering maximal bone conduction thresholds of the better ear at 38 dB HL to achieve an aided sound field threshold of at least 30 dB hearing level and an aided word recognition score of at least 75% for monosyllabic words.     

Active transcutaneous bone conduction implant: audiological results in paediatric patients with bilateral microtia associated with external auditory canal atresia

Objective: To describe, in terms of functional gain and word recognition, the audiological results of patients under 18 years of age implanted with the active bone conduction implant, Bonebridge?. Design: Retrospective case studies conducted by reviewing the medical records of patients receiving implants between 2014 and 2016 in the public health sector in Chile. Study sample: All patients implanted with the Bonebridge were included (N?=?15). Individuals who had bilateral conductive hearing loss, secondary to external ear malformations, were considered as candidates. Results: The average hearing threshold one month after switch on was 25.2?dB (95%CI 23.5–26.9). Hearing thresholds between 0.5 and 4?kHz were better when compared with bone conduction hearing aids. Best performance was observed at 4?kHz, where improvements to hearing were observed throughout the adaptation process. There was evidence of a significant increase in the recognition of monosyllables. Conclusions: The Bonebridge implant showed improvements to hearing thresholds and word recognition in paediatric patients with congenital conductive hearing loss.     

Comparison of hearing thresholds obtained with Baha preoperative assessment tools and those obtained with the osseointegrated implant

We conducted a study of the Baha bone-anchored hearing aid system to quantify the difference between (1) hearing thresholds obtained through preoperative testing methods with the Baha sound processor attached to three different bone-conduction testing devices and (2) thresholds obtained postoperatively with the sound processor attached to a surgically placed osseointegrated titanium implant. Twenty-three patients underwent free-field testing in four situations: with the Baha sound processor attached to (1) the Baha Testband (transcutaneous transmission), (2) the Baha Softband (transcutaneous transmission), (3) a test rod (bone conduction via the teeth), and (4) the osseointegrated implant (percutaneous transmission). The main outcome measure was the result of a comparison of the thresholds obtained with the three preoperative test methods and those obtained with the osseointegrated implant. We found that aided thresholds obtained with the osseointegrated implant were significantly better (p < 0.05) than those obtained with the three preoperative test methods. The degree of superiority increased with higher frequencies. We conclude that thresholds of 1 to 18 dB better than those obtained by preoperative test methods can be expected postoperatively with the osseointegrated implant. The damping effect of sound transmission via the teeth or transcutaneously must be accounted for in making predictions of postoperative outcome.     

The bone conduction implant: Clinical results of the first six patients

Objective: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin. Design: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device. Study sample: Six patients (age 18–67 years) with mild-to-moderate conductive or mixed hearing loss. Results: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was ? 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses. Conclusions: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.     

Comparative outcomes of active and passive hearing devices by transcutaneous bone conduction

Conclusion Bonebridge (BB) and Sophono (SP) devices improved hearing; with the BB implant showing a better performance at medium and high frequencies. Furthermore, the BB, as an active implant, showed higher functional gain and increased time of use, when compared to the SP, a passive system. Objectives This study aims to compare surgical and audiological outcomes of SP and BB devices in order to assess and further differentiate the indication criteria. Methods Fourteen patients with conductive and mixed hearing loss were evaluated pre- and post-operatively (BB or SP) (period 2013–2014). Age, gender, surgical history, cause and type of hearing loss, implant use per day, levels of bone and air conduction, and functional gain were recorded. Data was analysed by Wilcoxon singed-rank and Wilcoxon rank-sum tests. Results Fourteen patients (BB; n?=?10 and SP; n?=?4) with an average age?=?25.42 years (CI95?=?12.41–38.43) were evaluated. The gender relation was equal (1:1), with pre-implantation osseous thresholds of 20.42?dB (CI95?=?11.15–29.69), and pre-implantation aerial thresholds of 70.83?dB (CI95?=?62.52–79.14). The SP wearing time was significantly lower than that of the BB (SP?=?7–10?h/day, BB?=?8–12?h/day; p?=?0.0323). The functional gain did not differ significantly between the two devices (BB?=?40.00?±?13.19?dB, SP?=?34.06?±?15.63?dB; p?=?0.3434), but a significant improvement from pre- to post-implantation was observed (p?p?=?0.0140) and 4?kHz (p?相似文献   

Our auditory results using the Vibrant Soundbridge on the long process of the incus: 20 years of data

Objective

After 20 years of experience with different types of middle ear implants, we analyzed our database about the Vibrant Soundbridge (VSB) to know the rate of complications, the effect on the residual hearing and the audiometric gain in our center.

Amplification of transcutaneous and percutaneous bone-conduction devices with a test-band in an induced model of conductive hearing loss

Objective: Transcutaneous devices have a disadvantage, the dampening effect by soft tissue between the bone and devices. We investigated hearing outcomes with percutaneous and transcutaneous devices using test-bands in an induced unilateral conductive hearing loss. Design: Comparison of hearing outcomes of two devices in the same individuals. Study sample: The right ear was plugged in 30 subjects and a test-band with devices (Cochlear? Baha® BP110 Power and Sophono® Alpha-2 MPO?) was applied on the right mastoid tip with the left ear masked. Sound-field thresholds, speech recognition thresholds (SRTs), and word recognition scores (WRSs) were compared. Results: Aided thresholds of Sophono were significantly better than those of Baha at most frequencies. Sophono WRSs (86?±?12%) at 40?dB SPL and SRTs (14?±?5?dB HL) were significantly better than those (73?±?24% and 23?±?8?dB HL) of Baha. However, Sophono WRSs (98?±?3%) at 60?dB SPL did not differ from Baha WRSs (95?±?12%). Conclusion: Amplifications of the current transcutaneous device were not inferior to those of percutaneous devices with a test-band in subjects with normal bone-conduction thresholds. Since the percutaneous devices can increase the gain when fixed to the skull by eliminating the dampening effect, both devices are expected to provide sufficient hearing amplification.     

Integrated protocol of auricle reconstruction combined with hearing reconstruction

Conclusions. Speech understanding is better with the Baha Divino? than with the Baha® Compact in competing noise from the rear. No difference was found for speech understanding in quiet. Subjectively, overall sound quality and speech understanding were rated better for the Baha Divino?. Objectives. To compare speech understanding in quiet and in noise and subjective ratings for two different bone-anchored hearing aids: the recently developed Baha Divino? and the Baha® Compact. Patients and methods. Seven adults with bilateral conductive or mixed hearing losses who were users of a bone-anchored hearing aid were tested with the Baha® Compact in quiet and in noise. Tests were repeated after 3 months of use with the Baha Divino?. Results. There was no significant difference between the two types of Baha® for speech understanding in quiet when tested with German numbers and monosyllabic words at presentation levels between 50 and 80dB. For speech understanding in noise, an advantage of 2.3dB for the Baha Divino? vs the Baha® Compact was found, if noise was emitted from a loudspeaker to the rear of the listener and the directional microphone noise reduction system was activated. Subjectively, the Baha Divino? was rated statistically significantly better in terms of overall sound quality.     

Evaluation of long-term patient satisfaction and experience with the Baha® bone conduction implant

Abstract

Objective: Evaluate long-term patient satisfaction with bone-anchored hearing aids (the Baha^R, now referred to by Cochlear as a ‘bone conduction implant’) in our hospital clinic spanning the eighteen-year period from the inception of our Baha program. The researchers further wished to analyse the various factors leading to patient satisfaction/dissatisfaction with their Baha. We developed a new questionnaire to obtain a comprehensive impression of individual patient practices, general satisfaction, and experiences with their Baha in respect to time spent using Baha, sound quality, annoyance from noise disturbance, ease of communication, cosmetic appearance, and satisfaction with the Baha amongst patient relatives, an aspect not previously investigated. Design: The study design was retrospective and executed as a postal questionnaire. The questionnaire was developed by the authors of this paper. Study sample: Patients operated on for a Baha at our hospital from 1989 to 2007. Results: The response rate was 92.4%. Eighty-six percent were satisfied or very satisfied with their Baha. Ninety-one percent of respondents could communicate using their Baha in a one-on-one conversational setting. A primary factor leading to dissatisfaction, experienced by 70% of responding patients, was annoyance from wind noise. Conclusions: Baha was found to yield good overall patient satisfaction over the long-term, and it was possible to identify specific factors attributing to satisfaction/dissatisfaction.     

Inside implant criteria or not? – Detection of non-organic hearing loss during cochlear implant assessment

Objectives: The diagnosis of non-organic hearing loss (NOHL) is a difficult but important issue during the assessment process for cochlear implantation (CI). We aim to identify the key factors in identifying patients with NOHL during CI assessment and present our local screening protocol for NOHL.

Methods: A retrospective review of patients referred to the Yorkshire Auditory Implant Service (YAIS) between 2003 and 2015 who were subsequently diagnosed with NOHL during the assessment. Patient demographic data, audiological and functional assessments were assessed.

Results: Thirty-two patients were included in the study. Mean age was 43 years (range 14–82 years). Male to female ratio was 1:1.7. Indicators of possible NOHL included a sudden deterioration in hearing (n?=?21; 66%), mismatches in observed behaviour and either pure-tone audiogram (PTA) (n?=?27; 84%) or functional testing (n?=?20; 80%) and stapedial reflexes below reported audiological thresholds (n?=?12; 46%). A mismatch in functional hearing and PTA was seen in 72% of patients. Patients with suspected NOHL were referred for further objective testing. All 23 patients who underwent objective testing had better hearing levels compared to reported hearing thresholds thus placing them outside of implant criteria. Five candidates were found to have normal hearing thresholds.

Discussion: NOHL can present a significant challenge to the implant team, particularly in the subgroup with a pre-existing organic hearing loss with non-organic overlay. We discuss the common features in this cohort of patients.

Conclusions: To facilitate the identification of patients with NOHL, the YAIS has developed a screening protocol.     

Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window

Early clinical findings are reported for subjects implanted with the Vibrant Med-El Soundbridge® (VSB) device. The present criteria for the VSB, limiting its application to patients with normal middle ear function, have been extended to include patients with ossicular chain defects. Seven patients with severe mixed hearing loss were implanted with the transducer placed onto the round window. All had undergone previous surgery: six had multiple ossiculoplasties, and one had the VSB crimped on the incus with unsuccessful results. Round window implantation bypasses the normal conductive path and provides amplified input to the cochlea. Post-operative aided thresholds of 30 dB HL were achieved for most subjects, as compared with unaided thresholds ranging from 60–80 dB HL. Aided speech reception thresholds at 50% intelligibility were 50 dB HL, with most subjects reaching 100% intelligibility at conversational levels, while unaided thresholds averaged 80 dB HL, with only one subject reaching 100% intelligibility. These results suggest that round window implantation may offer a viable treatment option for individuals with severe mixed hearing losses who have undergone unsuccessful ossiculoplasties.     

Results of ossicular chain reconstruction with glass ionomer cement in pediatric patients

ObjectiveThe aim of our study was to analyze the hearing results of ossicular chain reconstruction in incus long process defects in pediatric patients.MethodsThis retrospective study included 15 pediatric patients that had incus long process defect due to chronic otitis media or adhesive otitis, and repaired with glass ionomer cement between 2009 and 2015. The audiological tests (air conduction thresholds, bone conduction thresholds, air bone gap) obtained preoperatively and one year after surgery were compared. In addition, preoperative and postoperative air bone gap differences were estimated to determine hearing gain.ResultsMean air conduction and air bone gaps decreased significantly one year after surgery when compared to the preoperative values (p< 0.001 for both). Mean hearing gain was 20.33 ± 6.36 dB one year after surgery.ConclusionUse of glass ionomer cement to repair incus long process defects is a suitable method that improves hearing in pediatric patients. Further large studies that compare glass ionomer cement ossiculoplasty with other ossicular reconstruction methods are needed.     

The Baha Softband. A new treatment for young children with bilateral congenital aural atresia

The Baha (bone-anchored hearing aid) Softband appears to be an effective mean of hearing rehabilitation for children with a congenital bilateral aural atresia who are too young for the amplification of a Baha on an implant. The aided hearing threshold with a Baha Softband is almost equal to that achieved with a conventional bone conductor. The speech development of the children studied with a Baha Softband is on a par with peers with good hearing.     

A retrospective study on post-operative hearing of middle ear cholesteatoma patients with labyrinthine fistula

Conclusions: There is no significant change in bone conduction threshold after operation, so the tympanoplasty can be done to maintain hearing when conditions allow. Objective: To study the impact of surgical treatment on hearing of cholesteatoma patients with labyrinthine fistula. Methods: The clinical data of 35 patients (35 ears) with labyrinthine fistula, which were caused by cholesteatoma, were analyzed retrospectively. The hearing of 21 patients was followed up. Results: Three months to 5 years follow-up of 21 patients were accomplished by pure tone audiometry and other details. There was no recurrent cholesteatoma in the patients. Compared with pre-operative average bone conduction at 0.5, 1, 2, 4, and 8 kHz, 12 cases had a difference less than 5 dB, three patients’ hearing improved (more than 10 dB), and five cases declined (more than 10 dB). One patient received cochlear implantation 3 months after the surgery. The average bone and air conduction thresholds at 0.5, 1, 2, 4, and 8 kHz had no obvious change (p?>?0.05) in 11 patients managed by a canal wall down mastoidectomy with tympanoplasty.     

Cochlear implant candidates with psychogenic hearing loss

Conclusions: Specific requests for cochlear implantations by persons with psychogenic hearing loss are a relatively new phenomenon. A number of features seems to be over-represented in this group of patients. The existence of these requests stresses the importance of auditory brainstem response (ABR) measurements before cochlear implantation. Objective: To describe the phenomenon of patients with psychogenic hearing losses specifically requesting cochlear implantation, and to gain first insights into the characteristics of this group. Methods: Analysis of all cases seen between 2004 and 2013 at the University Hospital of Bern, Switzerland. Results: Four cochlear implant candidates with psychogenic hearing loss were identified. All were female, aged 23–51 years. Hearing thresholds ranged from 86 dB to 112 dB HL (pure-tone average 500–4000 Hz). ABRs and otoacoustic emissions (OAEs) showed bilaterally normal hearing in two subjects, and hearing thresholds between 30 and 50 dB in the other two subjects. Three subjects suffered from depression and one from a pathologic fear of cancer. Three had a history of five or more previous surgeries. Three were smokers and three reported other close family members with hearing losses. All four were hearing aid users at the time of presentation.     

Phase III results with a totally implantable piezoelectric middle ear implant: Speech audiometry,spatial hearing and psychosocial adjustment

Objective To evaluate the treatment efficacy of an electromechanical middle ear amplifier implant (AI) in patients with chronic moderate-to-severe sensorineural hearing loss (SNHL). The AI is a piezoelectric system with a sound processor and a rechargeable battery within a hermetically sealed titanium canister. Its titanium-sealed microphone is placed in the bony region of the ear canal. The incus-coupled transducer (actuator), which is also inside a titanium casing, is fastened to the adjacent bone.

Material and Methods This was a phase III study comprising 20 intention-to-treat patients. Telemetrical adjustments followed electromechanical amplifier implantations. We used a word recognition test as our primary efficacy measure (Freiburg Speech Recognition Test; DIN 45621). Secondary efficacy measures were the sentence comprehension test (Goettinger Satztest, 1996) for auditory orientation within noisy and quiet environments and a psychosocial adjustment test (Gothenburg Profile Test, 1998). The 6-month follow-up comprised a complete medical examination. Nineteen patients completed the study (per-protocol patients; 100% reference).

Results Seventeen patients (89%) demonstrated improved binaural recognition of phonetically balanced monosyllables. Fourteen postoperative patients (74%) attained a perfect score (100%) on this test, compared to only 3 preoperative patients (16%). Thirteen patients (68%) reached the sentence recognition threshold at a 2:1 dB signal-to-noise ratio during noisy trials. Correct identification of the noise source direction in the horizontal plane occurred in 89% of the trials. The Gothenburg Profile Test scores showed that the subjective evaluation of hearing, orientation, social behavior and self-confidence increased from 48% to 88%. Three patients did not benefit from the implant.

Conclusion Treatment of SNHL with a totally implantable hearing system can be an efficient method for those patients unable to wear hearing aids. However, in order to avoid implantation in non-responders, there is a need for more specific audiological indication criteria.     

The evaluation of a surgery and the short-term benefits of a new active bone conduction hearing implant - the Osia®

IntroductionModern medicine offers a wide spectrum of different hearing devices, and bone conduction implants can be found among them.ObjectiveThe presentation of the outcomes of the implantation of a new active bone conduction hearing implant – the Osia®, and its comparison with the well-known passive transcutaneous system – the Baha® Attract.MethodsEight adult patients with bilateral mixed hearing loss were randomly divided into two groups. Group 1 was implanted with the Osia®, and group 2 was implanted with the Baha® Attract. The details of the surgery were analyzed, along with the functional and audiological results.ResultsIn all the cases, the surgery was successful, and the healing uneventful. In both groups, it was observed that pure tone audiometry and speech audiometry in free field improved significantly after the implantation (mean gain in pure tone audiometry for the Osia group 42.8 dB SPL and for the Baha group 38.8 dB SPL). In the Osia group, the results after the surgery were much better than with the Baha® 5 Power processor on the Softband. The patients implanted with the Osia® evaluated the quality of their hearing as being superior to those implanted with the Baha® Attract. There was an evident improvement in the abbreviated profile of hearing aid benefit questionnaire and in the speech, spatial and qualities of hearing scale for both systems. In the abbreviated profile of hearing aid benefit, changes were more evident in the Osia group (in global score 49% vs. 37.2%).ConclusionImplantation of the Osia® is an effective treatment option for the patients with bilateral mixed hearing loss. The surgery is safe but more complex and time-consuming than the Baha® Attract implantation. The preliminary audiological results as well as the overall quality of life indicate that the Osia® is a better solution than the Baha® Attract. However, future studies should be carried out to make further observations in a larger group of patients, and with longer follow-up.     

Outcomes of the Baha Attract System combined with auricle reconstruction in mandarin speaking patients with bilateral microtia-atresia

Background: A transcutaneous bone-conduction hearing device (tBCHD), the Baha Attract System has been recently introduced to China, and very few studies have assessed the efficacy of this system in speakers of mandarin.

Objectives: This study aims to analyze the functional and cosmetic outcomes of this system.

Materials and Methods: This prospective study included 11 patients (nine males, two females), of mean age 16 years (range 9–32 years). Seven patients were conducted the implantation simultaneously with auricle reconstruction, and the other four were before it. Auditory results were compared between unaided patients and implanted patients. Subjective satisfaction was analyzed using three questionnaires.

Results: The mean sound field thresholds were 65.9?±?5.1?dB SPL unaided and 30.9?±?4.7?dB SPL with an implanted Baha Attract System, resulting in a mean hearing gain of 35.0?±?6.7?dB. The mean WRS scores were 47.8?±?8.7% unaided and 92.1?±?2.0% with the Baha Attract System, resulting in a mean improvement of 47.8?±?8.7%. No adverse events were reported and questionnaires showed good patients satisfaction.

Conclusions: The transcutaneous Baha Attract System is effective in mandarin speaking patients, and the combination of hearing rehabilitation and auricle reconstruction surgery is promising for patients with bilateral microtia-atresia.     

Evaluation of residual hearing in cochlear implants candidates using auditory steady-state response

Conclusion: The correlations between behavioral and auditory steady-state response (ASSR) thresholds were significant at 500, 1000, 2000, and 4000 Hz. ASSR presented high sensitivity and specificity in the detection of residual hearing in cochlear implant candidates when compared with warble-tone audiometry. Objectives: To assess residual hearing in cochlear implant candidates by comparing the electrophysiological thresholds obtained in dichotic single-frequency ASSR with behavioral thresholds at 500, 1000, 2000, and 4000 Hz. Methods: This was a comparative study between ASSR and warble-tone audiometry thresholds in 40 cochlear implant candidates (80 ears) before cochlear implantation with bilateral severe-to-profound sensorineural hearing loss. Results: Thresholds were obtained in 62.5% of all frequencies evaluated in warble-tone audiometry and in 63.1% in the ASSR. ASSR sensitivity was 96% and specificity was 91.6%. Mean differences between behavioral and ASSR thresholds did not reach significance at any frequencies. Strong correlations between behavioral and ASSR thresholds were observed in 500, 1000, and 2000 Hz and moderate in 4000 Hz, with correlation coefficients varying from 0.65 to 0.81. On 90% of occasions, ASSR thresholds were acquired within 10 dB of behavioral thresholds.     

An evaluation of hearing preservation outcomes in routine cochlear implant care: Implications for candidacy

Introduction: A retrospective evaluation of pre- and post-operative audiometric data at a single large UK cochlear implant centre over 25 years was undertaken.

Methods: Analysis of pre-operative hearing levels showed that there was a modest but significant reduction in average pre-operative hearing thresholds among patients referred between 1990 and 2015, particularly in the low frequencies.

Outcomes: The proportion of those referred who would meet widely-accepted candidacy criteria for electro-acoustic stimulation (EAS) grew significantly over time but in the period 2011-2015 just 9% of those referred had sufficient residual hearing for EAS. On average, implant recipients lost 20 dB hearing at frequencies ≤1000 Hz as a result of the surgery.

Conclusions: The findings suggest that hearing preservation is now widely achievable, and that both candidacy criteria and referrer education should take into account potential EAS benefit.