External Sound Processor Research Articles

Initial Experiences with the Envoy Acclaim® Fully Implanted Cochlear Implant.

Introduction: Cochlear implantation has become the standard of care for the treatment of moderate-to-profound bilateral sensorineural hearing loss. However, current technologies, all of which rely on an external sound processor, have intrinsic limitations that prevent certain activities and diagnostics, thus hampering full integration into a patient's lifestyle. The Envoy Medical (White Bear Lake, MN, USA) Acclaim® fully implanted cochlear implant is a new device currently undergoing testing that has been designed to alleviate many of the current constraints by housing all components within the patient, thus allowing for near-constant use in many environments that are not conducive to a traditional cochlear implant. Methods: As part of an Early Feasibility Study, three adult implant candidates were implanted with the Acclaim® cochlear implant. Surgical video and photography were taken, and initial observations were recorded. Implantation with the Acclaim® device is largely similar to a traditional cochlear implant, with modifications to allow room for the implanted sensor as well as the implantation of a battery in the subcutaneous tissues of the chest. Results: This study demonstrates a step-by-step overview of implanting the Acclaim® and discusses initial insight and experiences with the first three implantations with this new device. Conclusions: All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices. Surgery is more technically challenging compared to a standard cochlear implant, but the skills needed can all be mastered by a dedicated otologic surgeon.

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®

PurposeThe new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017–2021) on audiological outcomes and hearing-related quality of life for the Osia system.MethodsBetween 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2.ResultsMean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires.ConclusionThe Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness.

Sound Processor Replacement in Patients with Cochlear Implant: Analysis of a 30-Year Single-Institutional Experience

Background and Objectives The purpose of this study is to investigate the replacement of external sound processors and to help understand the economic burden experienced from cochlear implant users.Subjects and Method Among the 500 cases of cochlear implant surgery from 1992 to 2019, 336 cases from 311 patients who had used a cochlear implant for more than 1 year were enrolled. The period of cochlear implant use, replacement of the sound processor, the number, method, and reason of replacements were examined.Results One hundred sixty cases (47.62%) replaced the sound processor at least once. There were a total of 213 replacements made in 160 cases. The most common reason for replacing the sound processors was because it could not be repaired (71 replacements, 33.33%), with their period of use being an average of 12 years. The most common replacement method of the sound processors was by purchasing with medical insurance benefits (100 replacements, 46.95%), with the usage period being an average of 11 years and 4 months.Conclusion Cochlear implant users replaced the sound processor for various reasons and the period of using one sound processor was relatively short. About half of all replacement cases were made by applying for medical insurance benefits. Others purchased directly through a sales company and paid a relatively high cost. Therefore, it is necessary to expand the medical insurance for external sound processor of cochlear implants to include exchange times considering the economic burden of cochlear implant users.

Device profile of the Bonebridge bone conduction implant system in hearing loss: an overview of its safety and efficacy

ABSTRACT Introduction The Bonebridge is an active transcutaneous semi-implantable bone conduction hearing device suitable for several types of hearing loss. It has unique benefits over some more established technologies. It consists of an internal active implant and an external sound processor. It was first launched in 2012, with a newer model released in late 2019. Areas covered The structure and features of the device are described. Indications, audiological criteria, and contraindications to implantation are discussed. The planning and procedure of implantation surgery are also described. Research outlining the outcomes of implant use and risk of adverse events is highlighted. Expert opinion The evidence included in this article demonstrates the successful audiological outcomes and patient satisfaction with Bonebridge implantation. The rate of adverse events following surgery is low and compares well with other devices which may be considered for Bonebridge candidates. The device should be considered as an option for suitable candidates and in many cases may be the better option available, given the low incidence of skin complications and the absence of a skin penetrating abutment. Future advances are likely to affect sound processor technology, connectivity, and possibly further reduction in implant size and gain.

Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation

Background: Bone-conduction hearing implants are standard of care devices.Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system.Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power® Sound Processor on a softband.Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device.Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.

Upgrade to Nucleus® 6 in Previous Generation Cochlear™ Sound Processor Recipients.

The Nucleus® 6 sound processor is now compatible with the Nucleus® 22 (CI22M)-Cochlear's first generation cochlear implant. The Nucleus 6 offers three new signal processing algorithms that purportedly facilitate improved hearing in background noise. These studies were designed to evaluate listening performance and user satisfaction with the Nucleus 6 sound processor. The research design was a prospective, single-participant, repeated measures design. A group of 80 participants implanted with various Nucleus internal implant devices (CI22M, CI24M, Freedom® CI24RE, CI422, and CI512) were recruited from a total of six North American sites. Participants had their external sound processor upgraded to the Nucleus 6 sound processor. Final speech perception testing in noise and subjective questionnaires were completed after four or 12 weeks of take-home use with the Nucleus 6. Speech perception testing in noise showed significant improvement and participants reported increased satisfaction with the Nucleus 6. These studies demonstrated the benefit of the new algorithms in the Nucleus 6 over previous generations of sound processors.

Long-Term Benefit Perception, Complications, and Device Malfunction Rate of Bone-Anchored Hearing Aid Implantation for Profound Unilateral Sensorineural Hearing Loss

To longitudinally evaluate short- and long-term subject satisfaction/benefit perception, device usage rates, complication rates, and external device repair rates of bone-anchored hearing aid (BAHA) implantation on a cohort of adult subjects with profound unilateral sensorineural hearing loss (PUSHL). Prospective clinical trial. Tertiary referral center. Fifty-six adults with PUSHL, 21 of which underwent BAHA implantation (followed for an average of 3.2 years after implantation; range, 0.8-4.6 yr). Short- and long-term satisfaction/benefit perception outcomes consisting of the Glasgow Hearing Aid Benefit Profile, Abbreviated Profile of Hearing Aid Benefit, and Single-Sided Deafness Questionnaire, including a comparison of results between implanted and nonimplanted subjects. Short- and long-term device usage rates, complications, and device failure issues also were carefully documented. There were statistically significant improvements in nearly all measures of benefit perception documented as well as a high rate of long-term device usage (81%). Although satisfaction and benefit perception outcomes generally tended to regress over time when compared with initial short-term outcomes, long-term scores still tended to be significantly improved nevertheless as compared with preoperative levels. Approximately 38% of implants experienced severe local skin reactions (Grade 2 and above) around the implant site at some point throughout the follow-up period, whereas only one (4.8%) required implant removal. 66.7% of subjects required repair of their external sound processor. BAHA implantation seems to provide a high level of short- and long-term perceived benefit and satisfaction in subjects with PUSHL and high rate of long-term device usage. Implant site adverse local skin reactions and repairs of the external sound processor were quite common.

Experiences with the new Audiant XA-II implant and the behind-the-ear (BTE) device.

Patients with large conductive hearing loss do not always tolerate conventional air conduction or bone conduction hearing aids. They can be helped sometimes with an implantable bone conductor device. The so-called bone-anchored hearing aid consists of an implantable titanium skull screw and an external sound processor unit. In this study, we report our experiences with 10 subjects who have been implanted with the recently improved Audiant screw-type XA-II and their experience with the newly developed behind-the-ear (BTE) external processor, the at-the-ear processor and the body-level device with a new transducer with variable magnetic strength. Evaluation shows that the Audiant XA-II system is well accepted and does not show any tissue reaction. The BTE processor is an important new complement to the Audiant system. Furthermore, the system is effective in compensating the air-bone gap almost completely at the higher frequencies but only partially at the lower ones. The maximum output appears to limit its feasibility for perceptive losses beyond 20 dB (PTA). When this system is utilized for proper hearing loss, however, the system usually improves speech intelligibility both in quiet and in background noise. When the system is prescribed for hearing losses with a moderate or large perceptive component, the system is ineffective and leads to negative evaluations.

Multichannel cochlear implantation: Utah-design.

The Utah-design multichannel cochlear implant consists of six intracochlear monopolar electrodes, one promontory electrode, and an indifferent electrode. Connection of the intracochlear system to the external sound processor is via a percutaneous pedestal system. Four of the intracochlear electrodes receive simultaneous stimulation. Twenty patients implanted at the University of Utah with more than 1 year of sound processor use were evaluated for the study. All patients wear their sound processors on a daily basis. Seven of the 20 are able to use the telephone without special devices. Nineteen patients were tested with open set CID sentences with an average 42.2% response. A comparison was made between live voice and taped voice open-set spondee word list performance, showing slightly better overall performance with live voice.

Multichannel Cochlear Implants

At the October 1985 meeting of the American Academy of Otolaryngology—Head and Neck Surgery in Atlanta, James L. Parkin, MD, Salt Lake City, reported his experience with multichannel cochlear implants. He stated that between April 1984 and February 1985, 13 adult, postlingually profoundly deaf patients were implanted with multichannel intracochlear electrode systems. Four of the intracochlear-stimulating electrodes were selected on the basis of their ability to receive simultaneous different stimuli via the external sound processor, because this system allows the coding of more complex sounds. All patients currently wear their sound processors on a daily basis, with an average daily use of 12.5 hours. Twelve of the 13 patients report improved performance with continued sound processor use. All patients would be willing to undergo implantation again based on current performance. The first patient implanted is now scoring 100% on open-set spondee word lists and CID (Central Institute for the Deaf)