The programming of CIs is essential for good performance. However, no Good Clinical Practice guidelines exist. This paper reports on the results of an inventory of the current practice worldwide. A questionnaire was distributed to 47 CI centers. They follow 47600 recipients in 17 countries and 5 continents. The results were discussed during a debate. Sixty-two percent of the results were verified through individual interviews during the following months. Most centers (72%) participated in a cross-sectional study logging 5 consecutive fitting sessions in 5 different recipients. Data indicate that general practice starts with a single switch-on session, followed by three monthly sessions, three quarterly sessions, and then annual sessions, all containing one hour of programming and testing. The main focus lies on setting maximum and, to a lesser extent, minimum current levels per electrode. These levels are often determined on a few electrodes and then extrapolated. They are mainly based on subjective loudness perception by the CI user and, to a lesser extent, on pure tone and speech audiometry. Objective measures play a small role as indication of the global MAP profile. Other MAP parameters are rarely modified. Measurable targets are only defined for pure tone audiometry. Huge variation exists between centers on all aspects of the fitting practice.

Extracellular vesicles (EVs) derived from the secretome of human mesenchymal stromal cells (MSC) contain numerous factors that are known to exert anti‐inflammatory effects. MSC‐EVs may serve as promising cell‐based therapeutics for the inner ear to attenuate inflammation‐based side effects from cochlear implantation which represents an unmet clinical need. In an individual treatment performed on a ‘named patient basis’, we intraoperatively applied allogeneic umbilical cord‐derived MSC‐EVs (UC‐MSC‐EVs) produced according to good manufacturing practice. A 55‐year‐old patient suffering from Menière's disease was treated with intracochlear delivery of EVs prior to the insertion of a cochlear implant. This first‐in‐human use of UC‐MSC‐EVs demonstrates the feasibility of this novel adjuvant therapeutic approach. The safety and efficacy of intracochlear EV‐application to attenuate side effects of cochlea implants have to be determined in controlled clinical trials.

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BackgroundIn cochlear implants (CI) measuring the electrically evoked compound action potential (ECAP) has become an important tool for verifying the electrode-nerve interface as well as establishing a basis for a map to program the speech processor. In a standard clinical setup recordings are averaged over 25–100 repetitions to allow for the detection of ECAPs within the noise floor. To obtain an amplitude growth function, these measurements are normally performed for 5–10 different stimulation levels. We evaluate a recording paradigm where the stimulation intensity is increased in quasi-continuous steps and instead of averaging repeated recordings with identical stimulation parameters, running averages over small intervals of stimulation levels are computed. The first visible nerve response was manually identified by two experts.ResultsBoth recording paradigms were evaluated in 39 cochlear implants, showing an on average lower threshold of the first nerve response for the quasi-continuous measurement paradigm (Wilcoxon signed-rank test, p = 6.2e−08) compared to the clinical standard paradigm. The mean maximal loudness over all implants and stimulation electrodes was 13% lower at the 80 pulses/s quasi-continuous paradigm compared to the 44 pulses/s clinical standard paradigm.ConclusionsBeside a more robust determination of the ECAP threshold, the proposed quasi-continuous stimulation paradigm results in a more robust behavioral feedback of the CI user upon the maximal acceptable loudness percept. Furthermore this paradigm can also reveal the fine-structure in the amplitude growth function.

When the impedance of an electrode contact is highly increased in a cochlear implant, a failure of the appropriate electrode seems obvious. We present a case where impedances of some electrodes were at the lower edge of the normal range and not regarded as suspicious neither by the clinical fitting software nor by in-vivo tests conducted by the implant manufacturer. However, speech comprehension was substantially degraded and sound perception distorted. Also, on the affected electrodes, loudness perception was compromised and responses of the electrically evoked compound action potential were no longer measureable. After re-implantation, the subjective sound percept was clear again and speech comprehension scored much better than before. Later, inspection of the explant revealed shorts on the device and the implant was classified as device failure. Our case shows the importance of collecting longitudinal data of cochlear implant patients, i.e. device related technical measurements and hearing performance data, and the consideration of all these data in cases of patient complaints or suspected implant failures.

Twenty years ago, cochlear implants (CI) were indicated only in cases of profound hearing loss or complete deafness. While from today's perspective the technology was clumsy and provided patients with only limited speech comprehension in quiet scenarios, successive advances in CI technology and the consequent substantial hearing improvements over time have since then resulted in continuous relaxation of indication criteria toward residual hearing. While achievements in implant and processor electronics have been one key factor for the ever-improving hearing performance, development of electro-acoustic CI systems-together with atraumatic implantation concepts-has led to enormous improvements in patients with low-frequency residual hearing. Manufactures have designed special processors with integrated hearing aid components for this patient group, which are capable of conveying acoustic and electric stimulation. A further milestone in improvement of hearing in challenging listening environments was the adoption of signal enhancement algorithms and assistive listening devices from the hearing aid industry. This article gives an overview of the current state of the art in the abovementioned areas of CI technology.

The time required to determine a TECAP threshold for a single electrode contact was found to be between 0.5 and 1 min.

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